LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
Official Title
A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
Acronym
LAPLACE-2
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 15, 2013Actual
Primary Completion Date
Nov 12, 2013Actual
Completion Date
Dec 4, 2013Actual
First Submitted Date
Jan 7, 2013
First Submission Date that Met QC Criteria
Jan 8, 2013
First Posted Date
Jan 9, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 1, 2015
Results First Submitted that Met QC Criteria
Nov 18, 2015
Results First Posted Date
Dec 22, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 2, 2014
Certification/Extension First Submitted that Passed QC Review
May 2, 2014
Certification/Extension First Posted Date
May 20, 2014Estimated
Last Update Submitted Date
Nov 4, 2022
Last Update Posted Date
Nov 8, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Detailed Description
Prior to the first randomization, participants entered a screening period to determine eligibility. During screening, all participants received subcutaneous placebo corresponding to the once monthly dose volume. Participants who completed the screening period and met eligibility criteria were randomized to 1 of 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg) for a 4 week lipid stabilization period based on statin therapy at the time of study entry (no statin use vs non-intensive statin use vs intensive statin use).
After the 4-week lipid-stabilization period, eligible patients taking rosuvastatin or simvastatin during the lipid-stabilization phase were then randomized to 1 of 4 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) or matching placebo (subcutaneous, every 2 weeks), or evolocumab (420 mg, subcutaneous, monthly) or matching placebo (subcutaneous, monthly). Patients taking atorvastatin during the lipid-stabilization phase were then randomized to 1 of 6 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) and placebo (oral, daily), evolocumab (420 mg, subcutaneous, monthly) and placebo (oral, daily), placebo (subcutaneous, every 2 weeks) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily), or placebo (subcutaneous, monthly) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily).
A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria, and undergoing both randomization procedures.
Participants randomized to simvastatin who were taking verapamil or diltiazem prior to randomization received simvastatin 10 mg once daily (QD) while participants who were taking amlodipine, amiodarone or ranolazine prior to randomization received simvastatin 20 mg QD. All other participants randomized to simvastatin received simvastatin 40 mg QD.
Conditions Module
Conditions
Hyperlipidemia
Keywords
High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,067Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
A10 PBO Q2W
Placebo Comparator
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A10 PBO QM
Placebo Comparator
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A10 EZE (Q2W)
Active Comparator
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once a day for up to 12 weeks.
Drug: Ezetimibe
Drug: Placebo to Evolocumab
Drug: Atorvastatin
A10 EZE (QM)
Active Comparator
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Evolocumab
Biological
Administered by subcutaneous injection
A10 EvoMab Q2W
A10 EvoMab QM
A80 EvoMab Q2W
A80 EvoMab QM
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 to ≤ 80 years of age
Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
Statin intolerance
New York Heart association (NYHA) III or IV heart failure
Uncontrolled hypertension
Uncontrolled cardiac arrhythmia
Type 1 diabetes, poorly controlled type 2 diabetes
2067 patients were first randomized to 1 of the 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg); 1899 were then randomized to blinded investigational product.
Randomization into the statin dose cohorts was stratified by entry statin therapy and by use of certain concomitant medications.
Recruitment Details
Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL.
First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A10 EvoMab QM
Experimental
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks
Biological: Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A80 PBO Q2W
Placebo Comparator
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A80 PBO QM
Placebo Comparator
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A80 EZE (Q2W)
Active Comparator
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe
Drug: Placebo to Evolocumab
Drug: Atorvastatin
A80 EZE (QM)
Active Comparator
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe
Drug: Placebo to Evolocumab
Drug: Atorvastatin
A80 EvoMab Q2W
Experimental
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
A80 EvoMab QM
Experimental
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
R5 PBO Q2W
Placebo Comparator
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Rosuvastatin
R5 PBO QM
Placebo Comparator
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Rosuvastatin
R5 EvoMab Q2W
Experimental
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab
Drug: Rosuvastatin
R5 EvoMab QM
Experimental
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab
Drug: Rosuvastatin
R40 PBO Q2W
Placebo Comparator
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Rosuvastatin
R40 PBO QM
Placebo Comparator
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Rosuvastatin
R40 EvoMab Q2W
Experimental
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab
Drug: Rosuvastatin
R40 EvoMab QM
Experimental
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab
Drug: Rosuvastatin
S40 PBO Q2W
Placebo Comparator
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Simvastatin
S40 PBO QM
Placebo Comparator
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab
Drug: Simvastatin
S40 EvoMab Q2W
Experimental
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab
Drug: Simvastatin
S40 EvoMab QM
Experimental
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab
Drug: Simvastatin
R40 EvoMab Q2W
R40 EvoMab QM
R5 EvoMab Q2W
R5 EvoMab QM
S40 EvoMab Q2W
S40 EvoMab QM
AMG 145
Repatha
Ezetimibe
Drug
Administered orally once a day
A10 EZE (Q2W)
A10 EZE (QM)
A80 EZE (Q2W)
A80 EZE (QM)
Zetia
Placebo to Evolocumab
Drug
Administered by subcutaneous injection
A10 EZE (Q2W)
A10 EZE (QM)
A10 PBO Q2W
A10 PBO QM
A80 EZE (Q2W)
A80 EZE (QM)
A80 PBO Q2W
A80 PBO QM
R40 PBO Q2W
R40 PBO QM
R5 PBO Q2W
R5 PBO QM
S40 PBO Q2W
S40 PBO QM
Placebo to Ezetimibe
Drug
Administered orally once a day
A10 EvoMab Q2W
A10 EvoMab QM
A10 PBO Q2W
A10 PBO QM
A80 EvoMab Q2W
A80 EvoMab QM
A80 PBO Q2W
A80 PBO QM
Atorvastatin
Drug
Administered orally once a day
A10 EZE (Q2W)
A10 EZE (QM)
A10 EvoMab Q2W
A10 EvoMab QM
A10 PBO Q2W
A10 PBO QM
A80 EZE (Q2W)
A80 EZE (QM)
A80 EvoMab Q2W
A80 EvoMab QM
A80 PBO Q2W
A80 PBO QM
Lipitor
Rosuvastatin
Drug
Administered orally once a day
R40 EvoMab Q2W
R40 EvoMab QM
R40 PBO Q2W
R40 PBO QM
R5 EvoMab Q2W
R5 EvoMab QM
R5 PBO Q2W
R5 PBO QM
Crestor
Simvastatin
Drug
Administered orally once a day
S40 EvoMab Q2W
S40 EvoMab QM
S40 PBO Q2W
S40 PBO QM
Zocor
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Baseline and Week 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Baseline and Week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Weeks 10 and 12
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Baseline and Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Baseline and Week 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
Baseline and Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.
Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
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Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
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Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.
May HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
FG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
FG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
FG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
FG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
FG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
FG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
FG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
FG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
FG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
FG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
FG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
FG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
FG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
FG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
FG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
FG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
FG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
FG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
FG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
FG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
FG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
FG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
FG00056 subjects
FG00155 subjects
FG00256 subjects
FG00355 subjects
FG004110 subjects
FG005110 subjects
FG00655 subjects
FG00755 subjects
FG00856 subjects
FG00954 subjects
FG010110 subjects
FG011110 subjects
FG01258 subjects
FG01357 subjects
FG014114 subjects
FG015115 subjects
FG01656 subjects
FG01756 subjects
FG018111 subjects
FG019112 subjects
FG02056 subjects
FG02155 subjects
FG022112 subjects
FG023115 subjects
Received Treatment
FG00056 subjects
FG00155 subjects
FG00256 subjects
FG00355 subjects
FG004110 subjects
FG005110 subjects
FG00655 subjects
FG00755 subjects
FG00856 subjects
FG00954 subjects
FG010109 subjects
FG011110 subjects
FG01258 subjects
FG01357 subjects
FG014113 subjects
FG015115 subjects
FG01656 subjects
FG01755 subjects
FG018111 subjects
FG019112 subjects
FG02056 subjects
FG02155 subjects
FG022112 subjects
FG023115 subjects
COMPLETED
FG00054 subjects
FG00154 subjects
FG00251 subjects
FG00355 subjects
FG004108 subjects
FG005107 subjects
FG00648 subjects
FG00755 subjects
FG00853 subjects
FG00953 subjects
FG010102 subjects
FG011108 subjects
FG01254 subjects
FG01357 subjects
FG014102 subjects
FG015112 subjects
FG01655 subjects
FG01755 subjects
FG018105 subjects
FG019110 subjects
FG02052 subjects
FG02154 subjects
FG022109 subjects
FG023113 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG0042 subjects
FG0053 subjects
FG0067 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
FG0108 subjects
FG0112 subjects
FG0124 subjects
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FG01412 subjects
FG0153 subjects
FG0161 subjects
FG0171 subjects
FG0186 subjects
FG0192 subjects
FG0204 subjects
FG0211 subjects
FG0223 subjects
FG0232 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0064 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0102 subjects
FG0112 subjects
FG0122 subjects
FG0130 subjects
FG0146 subjects
FG0153 subjects
FG0160 subjects
FG0171 subjects
FG0181 subjects
FG0191 subjects
FG0202 subjects
FG0211 subjects
FG0222 subjects
FG0231 subjects
Decision by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
BG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
BG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
BG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
BG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
BG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
BG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
BG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
BG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
BG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
BG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
BG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
BG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
BG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
BG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
BG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
BG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
BG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
BG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
BG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
BG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
BG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
BG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
BG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
BG024
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG00155
BG00256
BG00355
BG004110
BG005110
BG00655
BG00755
BG00856
BG00954
BG010110
BG011110
BG01258
BG01357
BG014114
BG015115
BG01656
BG01756
BG018111
BG019112
BG02056
BG02155
BG022112
BG023115
BG0241899
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.3± 10.5
BG00162.2± 10.4
BG00261.0± 9.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00128
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0003
BG0012
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Stratification Factor: Entry Statin Therapy
Intensive statin use was defined as daily atorvastatin (40 mg or greater), rosuvastatin (20 mg or greater), simvastatin (80 mg), or any statin plus ezetimibe.
Data are provided for the full analysis set (all participants randomized to investigational product (IP) who received at least 1 dose of IP (subcutaneously or orally). Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000149.1± 46.9
BG001
Apolipoprotein B Concentration
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG00095.3± 26.0
BG001
Total Cholesterol/HDL-C Ratio
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Mean
Standard Deviation
ratio
Title
Denominators
Categories
Title
Measurements
BG0003.988± 1.154
BG001
Apolipoprotein B/Apolipoprotein A1 Ratio
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Mean
Standard Deviation
ratio
Title
Denominators
Categories
Title
Measurements
BG0000.666± 0.216
BG001
Lipoprotein(a) Concentration
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Median
Inter-Quartile Range
nmol/L
Title
Denominators
Categories
Title
Measurements
BG00031.5(13.0 to 87.5)
BG001
Triglyceride Concentration
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Median
Inter-Quartile Range
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000112.0(83.0 to 176.0)
BG001
Very Low Density Lipoprotein Cholesterol (VLDL-C) Concentration
Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Median
Inter-Quartile Range
mg/dL
Title
Denominators
Categories
Title
Measurements
BG00022.0(17.0 to 35.0)
BG001
HDL-C Concentration
Data are provided for the full anlaysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG00054.1± 16.6
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.86± 2.53
OG0010.97± 2.82
OG002-21.96± 2.63
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-71.42
Standard Error of the Mean
3.11
2-Sided
95
-77.55
-65.29
Primary
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Change From Baseline in LDL-C at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Apolipoprotein B at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Full analysis set
Posted
Number
95% Confidence Interval
percentage of participants
Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Secondary
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Full analysis set
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Lipoprotein(a) at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Triglycerides at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Secondary
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Weeks 10 and 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Secondary
Percent Change From Baseline in HDL-C at Week 12
Full analysis set
Posted
Least Squares Mean
Standard Error
percent change
Baseline and Week 12
ID
Title
Description
OG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
OG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
OG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
OG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
Time Frame
From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
1
56
5
56
EG001
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
2
55
3
55
EG002
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
0
56
9
56
EG003
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
0
55
6
55
EG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
4
110
9
110
EG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
2
110
7
110
EG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
2
55
7
55
EG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
1
55
13
55
EG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
1
56
8
56
EG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
1
54
2
54
EG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
3
109
11
109
EG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
1
110
9
110
EG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
1
58
11
58
EG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
2
57
1
57
EG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
3
113
6
113
EG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
3
115
9
115
EG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
2
56
3
56
EG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
1
55
8
55
EG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
1
111
5
111
EG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
3
112
8
112
EG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
0
56
3
56
EG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
1
55
5
55
EG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
2
112
18
112
EG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
1
115
11
115
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute coronary syndrome
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG0030 affected55 at risk
EG0041 affected110 at risk
EG0050 affected110 at risk
EG0060 affected55 at risk
EG0070 affected55 at risk
EG0080 affected56 at risk
EG0090 affected54 at risk
EG0100 affected109 at risk
EG0110 affected110 at risk
EG0120 affected58 at risk
EG0130 affected57 at risk
EG0140 affected113 at risk
EG0150 affected115 at risk
EG0160 affected56 at risk
EG0170 affected55 at risk
EG0180 affected111 at risk
EG0190 affected112 at risk
EG0200 affected56 at risk
EG0210 affected55 at risk
EG0220 affected112 at risk
EG0230 affected115 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected55 at risk
EG0020 affected56 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Herpes simplex meningoencephalitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Infected bites
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected55 at risk
EG0020 affected56 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Troponin increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Lung adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Pleomorphic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Coma
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Glomerulonephritis acute
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG0030 affected55 at risk
EG0040 affected110 at risk
EG0050 affected110 at risk
EG0061 affected55 at risk
EG0070 affected55 at risk
EG0081 affected56 at risk
EG0090 affected54 at risk
EG0100 affected109 at risk
EG0110 affected110 at risk
EG0120 affected58 at risk
EG0130 affected57 at risk
EG0141 affected113 at risk
EG0150 affected115 at risk
EG0160 affected56 at risk
EG0170 affected55 at risk
EG0180 affected111 at risk
EG0190 affected112 at risk
EG0200 affected56 at risk
EG0210 affected55 at risk
EG0222 affected112 at risk
EG0230 affected115 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0020 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0023 affected56 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0021 affected56 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected56 at risk
EG0012 affected55 at risk
EG0022 affected56 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected55 at risk
EG0022 affected56 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected56 at risk
EG0011 affected55 at risk
EG0021 affected56 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen Inc.
866-572-6436
ID
Term
D006949
Hyperlipidemias
D006937
Hypercholesterolemia
Ancestor Terms
ID
Term
D050171
Dyslipidemias
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C577155
evolocumab
D000069438
Ezetimibe
D000069059
Atorvastatin
D000068718
Rosuvastatin Calcium
D019821
Simvastatin
Ancestor Terms
ID
Term
D001384
Azetidines
D001385
Azetines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011758
Pyrroles
D001393
Azoles
D006538
Heptanoic Acids
D005227
Fatty Acids
D008055
Lipids
D013449
Sulfonamides
D000577
Amides
D009930
Organic Chemicals
D005464
Fluorobenzenes
D006845
Hydrocarbons, Fluorinated
D006846
Hydrocarbons, Halogenated
D006838
Hydrocarbons
D013450
Sulfones
D013457
Sulfur Compounds
D011743
Pyrimidines
D008148
Lovastatin
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0106 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0145 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0184 subjects
FG0190 subjects
FG0202 subjects
FG0210 subjects
FG0221 subjects
FG0230 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0191 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0231 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0161 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
60.6
± 9.2
BG00458.3± 8.4
BG00559.6± 11.1
BG00657.1± 9.9
BG00758.8± 11.5
BG00860.5± 10.2
BG00961.1± 8.9
BG01059.7± 10.2
BG01160.1± 10.2
BG01261.2± 9.1
BG01359.6± 9.2
BG01458.9± 11.2
BG01559.3± 10.5
BG01660.2± 8.7
BG01758.3± 11.3
BG01859.5± 9.2
BG01959.6± 9.0
BG02061.9± 9.7
BG02161.5± 10.3
BG02259.7± 9.2
BG02361.5± 9.6
BG02459.8± 9.9
29
BG00328
BG00456
BG00544
BG00622
BG00724
BG00824
BG00928
BG01044
BG01148
BG01235
BG01327
BG01452
BG01551
BG01621
BG01727
BG01843
BG01952
BG02032
BG02128
BG02245
BG02359
BG024871
Male
BG00032
BG00127
BG00227
BG00327
BG00454
BG00566
BG00633
BG00731
BG00832
BG00926
BG01066
BG01162
BG01223
BG01330
BG01462
BG01564
BG01635
BG01729
BG01868
BG01960
BG02024
BG02127
BG02267
BG02356
BG0241028
2
BG0031
BG0045
BG0052
BG0065
BG0075
BG0084
BG0094
BG0105
BG0117
BG0122
BG0134
BG0146
BG0153
BG0162
BG0173
BG0186
BG0195
BG0201
BG0212
BG0223
BG0235
BG02487
Not Hispanic or Latino
Title
Measurements
BG00053
BG00153
BG00254
BG00354
BG004105
BG005108
BG00650
BG00750
BG00852
BG00950
BG010105
BG011103
BG01256
BG01353
BG014108
BG015112
BG01654
BG01753
BG018105
BG019107
BG02055
BG02153
BG022109
BG023110
BG0241812
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0221
BG0230
BG0241
Asian
Title
Measurements
BG0001
BG0010
BG0022
BG0031
BG0043
BG0054
BG0061
BG0070
BG0080
BG0093
BG0101
BG0111
BG0120
BG0130
BG0142
BG0151
BG0161
BG0170
BG0180
BG0190
BG0203
BG0210
BG0221
BG0230
BG02425
Black or African American
Title
Measurements
BG0003
BG0010
BG0021
BG0032
BG0049
BG0054
BG0061
BG0072
BG0083
BG0094
BG0103
BG0114
BG0122
BG0131
BG0147
BG0155
BG0160
BG0173
BG0185
BG0193
BG0203
BG0211
BG0224
BG0235
BG02475
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
BG0160
BG0170
BG0180
BG0190
BG0201
BG0210
BG0220
BG0230
BG0244
White
Title
Measurements
BG00052
BG00155
BG00253
BG00352
BG00497
BG005101
BG00651
BG00752
BG00853
BG00946
BG010105
BG011105
BG01256
BG01356
BG014104
BG015107
BG01655
BG01752
BG018105
BG019109
BG02049
BG02154
BG022106
BG023110
BG0241785
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0062
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG0141
BG0151
BG0160
BG0171
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0247
Mixed Race
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0181
BG0190
BG0200
BG0210
BG0220
BG0230
BG0242
BG00210
BG00314
BG00428
BG00535
BG00615
BG00712
BG00821
BG00911
BG01034
BG01135
BG01213
BG01313
BG01433
BG01538
BG01613
BG01713
BG01833
BG01937
BG02019
BG02113
BG02231
BG02334
BG024542
Non-intensive statin use
Title
Measurements
BG00020
BG00125
BG00230
BG00321
BG00452
BG00540
BG00622
BG00727
BG00822
BG00921
BG01047
BG01146
BG01225
BG01328
BG01449
BG01542
BG01623
BG01722
BG01850
BG01944
BG02021
BG02126
BG02245
BG02348
BG024796
No statin use
Title
Measurements
BG00018
BG00111
BG00216
BG00320
BG00430
BG00535
BG00618
BG00716
BG00813
BG00922
BG01029
BG01129
BG01220
BG01316
BG01432
BG01535
BG01620
BG01721
BG01828
BG01931
BG02016
BG02116
BG02236
BG02333
BG024561
123.7
± 47.9
BG002126.8± 49.6
BG003119.3± 28.1
BG004124.2± 43.4
BG005126.1± 50.4
BG006100.3± 36.2
BG00794.7± 31.9
BG00898.7± 34.0
BG00992.3± 19.3
BG01094.2± 34.8
BG01193.8± 32.3
BG012115.6± 39.8
BG013119.9± 39.1
BG014118.7± 40.9
BG015122.9± 42.0
BG01677.4± 20.9
BG017102.9± 49.3
BG01888.5± 31.5
BG01988.5± 31.3
BG020110.3± 28.0
BG021108.6± 30.9
BG022114.9± 34.5
BG023123.7± 48.5
BG024109.1± 41.1
147.7
± 51.4
BG002153.8± 53.2
BG003148.3± 36.8
BG004152.3± 45.6
BG005154.3± 53.1
BG006124.2± 39.3
BG007116.5± 35.7
BG008124.8± 35.4
BG009118.4± 25.5
BG010120.2± 42.3
BG011117.2± 36.3
BG012141.1± 41.6
BG013148.3± 43.3
BG014146.6± 43.2
BG015152.0± 46.4
BG016103.9± 25.7
BG017128.7± 53.4
BG018113.5± 36.0
BG019114.3± 34.7
BG020138.4± 29.3
BG021135.7± 38.4
BG022146.8± 41.8
BG023151.2± 51.5
BG024150.3± 27.6
95.3
± 29.6
BG002101.3± 31.2
BG00394.6± 20.4
BG00499.7± 26.4
BG00597.3± 28.9
BG00681.1± 22.1
BG00780.1± 21.4
BG00885.3± 23.1
BG00978.7± 16.9
BG01079.9± 25.1
BG01177.9± 21.5
BG01293.1± 27.3
BG01395.9± 25.2
BG01495.4± 27.0
BG01597.2± 26.9
BG01671.0± 16.6
BG01784.8± 29.7
BG01877.4± 22.3
BG01978.7± 23.1
BG02091.6± 18.4
BG02189.8± 20.7
BG02294.2± 24.0
BG02396.5± 27.5
BG02489.1± 26.1
3.859
± 1.396
BG0024.112± 1.311
BG0034.002± 1.100
BG0043.980± 1.224
BG0054.100± 1.636
BG0063.704± 1.260
BG0073.461± 1.093
BG0083.748± 1.099
BG0093.540± 1.100
BG0103.696± 1.371
BG0113.462± 1.000
BG0124.044± 1.685
BG0133.891± 1.234
BG0143.915± 1.216
BG0154.178± 1.932
BG0163.086± 0.728
BG0173.547± 1.355
BG0183.413± 1.355
BG0193.307± 1.061
BG0203.733± 1.079
BG0213.595± 1.345
BG0224.196± 1.436
BG0233.924± 1.420
BG0243.786± 1.353
0.647
± 0.266
BG0020.692± 0.243
BG0030.640± 0.169
BG0040.663± 0.217
BG0050.659± 0.249
BG0060.603± 0.221
BG0070.571± 0.189
BG0080.640± 0.234
BG0090.560± 0.157
BG0100.593± 0.227
BG0110.562± 0.171
BG0120.661± 0.273
BG0130.636± 0.207
BG0140.640± 0.249
BG0150.676± 0.341
BG0160.479± 0.129
BG0170.562± 0.217
BG0180.538± 0.227
BG0190.536± 0.193
BG0200.611± 0.179
BG0210.581± 0.174
BG0220.657± 0.193
BG0230.639± 0.224
BG0240.614± 0.229
41.0
(15.0 to 106.0)
BG00237.0(9.5 to 190.0)
BG00333.0(8.0 to 163.0)
BG00427.0(8.0 to 120.0)
BG00549.0(11.0 to 169.0)
BG00653.0(15.0 to 177.0)
BG00750.0(13.0 to 152.0)
BG00825.0(12.0 to 108.0)
BG00961.5(12.0 to 192.0)
BG01032.0(11.5 to 135.5)
BG01124.5(8.0 to 93.0)
BG01234.0(8.0 to 158.0)
BG01335.0(14.0 to 156.5)
BG01438.0(11.0 to 165.0)
BG01532.0(9.0 to 172.0)
BG01628.5(7.0 to 171.0)
BG01733.0(11.0 to 148.0)
BG01841.0(10.0 to 183.0)
BG01949.5(11.0 to 184.5)
BG02036.5(17.5 to 140.5)
BG02128.0(13.0 to 180.0)
BG02232.5(13.0 to 157.0)
BG02337.0(11.0 to 141.0)
BG02434.0(11.0 to 161.5)
108.0
(83.0 to 145.0)
BG002129.5(94.0 to 151.5)
BG003119.0(87.0 to 168.0)
BG004135.0(99.0 to 189.0)
BG005119.0(84.0 to 161.0)
BG006104.0(82.0 to 142.0)
BG007104.0(76.0 to 124.0)
BG008133.0(89.0 to 155.0)
BG009109.0(80.0 to 171.0)
BG010104.0(81.0 to 163.0)
BG011106.5(79.0 to 137.0)
BG012112.5(89.0 to 148.0)
BG013134.0(86.0 to 184.0)
BG014116.0(90.0 to 168.0)
BG015121.0(93.0 to 161.0)
BG016128.0(91.5 to 162.0)
BG017116.0(78.0 to 160.0)
BG018102.0(79.0 to 151.0)
BG019119.5(87.0 to 149.5)
BG020124.0(90.0 to 173.0)
BG021106.0(87.0 to 139.0)
BG022129.0(91.5 to 195.0)
BG023110.0(84.0 to 161.0)
BG024116.0(86.0 to 158.0)
22.0
(17.0 to 29.0)
BG00225.5(19.0 to 30.0)
BG00324.0(17.0 to 33.0)
BG00427.0(20.0 to 38.0)
BG00524.0(17.0 to 32.0)
BG00621.0(16.0 to 28.0)
BG00721.0(15.0 to 25.0)
BG00826.5(18.0 to 31.0)
BG00922.0(16.0 to 34.0)
BG01021.0(16.0 to 33.0)
BG01121.0(16.0 to 27.0)
BG01222.5(18.0 to 30.0)
BG01327.0(17.0 to 37.0)
BG01423.0(18.0 to 34.0)
BG01524.0(19.0 to 32.0)
BG01626.0(18.5 to 32.5)
BG01723.0(16.0 to 32.0)
BG01820.0(16.0 to 30.0)
BG01924.0(17.0 to 30.0)
BG02025.0(18.0 to 34.5)
BG02121.0(17.0 to 26.0)
BG02226.0(18.5 to 39.0)
BG02322.0(17.0 to 32.0)
BG02423.0(17.0 to 32.0)
57.9
± 18.4
BG00254.1± 17.2
BG00352.7± 13.7
BG00456.0± 17.9
BG00556.1± 17.8
BG00650.6± 15.6
BG00750.9± 13.0
BG00848.7± 12.6
BG00951.6± 15.1
BG01048.5± 12.9
BG01150.8± 13.5
BG01252.1± 14.9
BG01355.5± 16.0
BG01454.5± 15.0
BG01554.0± 16.0
BG01652.8± 12.9
BG01756.0± 18.7
BG01853.2± 16.4
BG01953.8± 14.6
BG02055.0± 14.2
BG02159.9± 21.8
BG02249.7± 12.6
BG02357.3± 17.4
BG02453.5± 15.9
55
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
-17.08
± 2.78
OG004-61.56± 1.81
OG005-58.19± 1.99
OG00614.49± 4.42
OG00711.83± 3.85
OG008-14.60± 4.29
OG009-19.80± 3.85
OG010-61.80± 3.04
OG011-58.68± 2.74
OG0128.12± 2.68
OG0135.10± 2.62
OG014-60.09± 1.94
OG015-59.40± 1.87
OG0169.42± 3.60
OG0172.59± 4.30
OG018-58.89± 2.58
OG019-52.40± 2.98
OG0204.70± 3.61
OG0213.40± 4.94
OG022-65.86± 3.05
OG023-57.02± 3.93
Superiority or Other (legacy)
OG001
OG005
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.16
Standard Error of the Mean
3.44
2-Sided
95
-65.94
-52.38
Superiority or Other (legacy)
OG002
OG004
The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-39.60
Standard Error of the Mean
3.15
2-Sided
95
-45.81
-33.40
Superiority or Other (legacy)
OG003
OG005
The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-41.10
Standard Error of the Mean
3.41
2-Sided
95
-47.83
-34.37
Superiority or Other (legacy)
OG006
OG010
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-76.29
Standard Error of the Mean
5.36
2-Sided
95
-86.87
-65.72
Superiority or Other (legacy)
OG007
OG011
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-70.51
Standard Error of the Mean
4.72
2-Sided
95
-79.81
-61.20
Superiority or Other (legacy)
OG008
OG010
The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-47.20
Standard Error of the Mean
5.24
2-Sided
95
-57.54
-36.86
Superiority or Other (legacy)
OG009
OG011
The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-38.88
Standard Error of the Mean
4.73
2-Sided
95
-48.21
-29.56
Superiority or Other (legacy)
OG012
OG014
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-68.21
Standard Error of the Mean
3.30
2-Sided
95
-74.72
-61.70
Superiority or Other (legacy)
OG013
OG015
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-64.49
Standard Error of the Mean
3.21
2-Sided
95
-70.84
-58.14
Superiority or Other (legacy)
OG016
OG018
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-68.31
Standard Error of the Mean
4.42
2-Sided
95
-77.04
-59.57
Superiority or Other (legacy)
OG017
OG019
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.98
Standard Error of the Mean
5.23
2-Sided
95
-65.31
-44.65
Superiority or Other (legacy)
OG020
OG022
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-70.56
Standard Error of the Mean
3.12
2-Sided
95
-76.72
-64.41
Superiority or Other (legacy)
OG021
OG023
The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.41
Standard Error of the Mean
4.41
2-Sided
95
-69.11
-51.72
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0008.54± 2.24
OG0010.35± 2.60
OG002-23.88± 2.34
OG003-18.98± 2.57
OG004-61.41± 1.61
OG005-62.47± 1.83
OG00613.12± 3.99
OG0079.76± 3.39
OG008-16.85± 3.88
OG009-21.25± 3.42
OG010-61.80± 2.77
OG011-65.05± 2.42
OG0127.55± 2.39
OG0132.79± 2.50
OG014-59.33± 1.74
OG015-63.79± 1.76
OG0166.57± 3.11
OG017-0.02± 3.51
OG018-59.08± 2.23
OG019-62.94± 2.44
OG0203.26± 3.40
OG0216.00± 4.80
OG022-66.17± 2.93
OG023-62.45± 3.85
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-69.95
Standard Error of the Mean
2.76
2-Sided
95
-75.38
-64.51
Superiority or Other (legacy)
OG001
OG005
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-62.82
Standard Error of the Mean
3.17
2-Sided
95
-69.06
-56.57
Superiority or Other (legacy)
OG002
OG004
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.53
Standard Error of the Mean
2.79
2-Sided
95
-43.03
-32.03
Superiority or Other (legacy)
OG003
OG005
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-43.49
Standard Error of the Mean
3.15
2-Sided
95
-49.70
-37.28
Superiority or Other (legacy)
OG006
OG010
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-74.92
Standard Error of the Mean
4.85
2-Sided
95
-84.49
-65.35
Superiority or Other (legacy)
OG007
OG011
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-74.81
Standard Error of the Mean
4.15
2-Sided
95
-83.00
-66.62
Superiority or Other (legacy)
OG008
OG010
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.95
Standard Error of the Mean
4.75
2-Sided
95
-54.32
-35.57
Superiority or Other (legacy)
OG009
OG011
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-43.81
Standard Error of the Mean
4.19
2-Sided
95
-52.06
-35.55
Superiority or Other (legacy)
OG012
OG014
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-66.88
Standard Error of the Mean
2.93
2-Sided
95
-72.67
-61.08
Superiority or Other (legacy)
OG013
OG015
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-66.58
Standard Error of the Mean
3.05
2-Sided
95
-72.60
-60.56
Superiority or Other (legacy)
OG016
OG018
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-65.66
Standard Error of the Mean
3.81
2-Sided
95
-73.19
-58.12
Superiority or Other (legacy)
OG017
OG019
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-62.91
Standard Error of the Mean
4.27
2-Sided
95
-71.37
-54.46
Superiority or Other (legacy)
OG020
OG022
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-69.43
Standard Error of the Mean
2.74
2-Sided
95
-74.86
-64.01
Superiority or Other (legacy)
OG021
OG023
The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-68.45
Standard Error of the Mean
4.17
2-Sided
95
-76.68
-60.22
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.8± 3.7
OG001-0.4± 4.4
OG002-32.4± 3.8
OG003-25.1± 4.3
OG004-76.8± 2.7
OG005-80.1± 3.1
OG00611.0± 5.0
OG0075.5± 3.7
OG008-13.0± 4.9
OG009-21.3± 3.7
OG010-58.8± 3.5
OG011-60.1± 2.6
OG0126.5± 3.5
OG0130.1± 4.2
OG014-68.9± 2.5
OG015-77.8± 3.0
OG0163.4± 3.0
OG017-4.8± 4.2
OG018-52.3± 2.2
OG019-55.3± 2.9
OG020-5.7± 5.2
OG0211.7± 6.5
OG022-83.8± 4.5
OG023-78.4± 5.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-83.6
Standard Error of the Mean
4.5
2-Sided
95
-92.6
-74.6
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-79.7
Standard Error of the Mean
5.3
2-Sided
95
-90.2
-69.2
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.4
Standard Error of the Mean
4.4
2-Sided
95
-53.4
-35.3
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-55.0
Standard Error of the Mean
5.3
2-Sided
95
-65.4
-44.6
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-69.9
Standard Error of the Mean
6.1
2-Sided
95
-81.9
-57.8
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-65.6
Standard Error of the Mean
4.5
2-Sided
95
-74.5
-56.7
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-45.8
Standard Error of the Mean
6.0
2-Sided
95
-57.7
-33.9
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-38.8
Standard Error of the Mean
4.5
2-Sided
95
-47.8
-29.9
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-75.4
Standard Error of the Mean
4.3
2-Sided
95
-83.9
-67.0
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-77.9
Standard Error of the Mean
5.1
2-Sided
95
-88.0
-67.8
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-55.8
Standard Error of the Mean
3.7
2-Sided
95
-63.1
-48.4
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-50.6
Standard Error of the Mean
5.1
2-Sided
95
-60.6
-40.6
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-78.1
Standard Error of the Mean
4.1
2-Sided
95
-86.2
-70.0
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-80.1
Standard Error of the Mean
5.8
2-Sided
95
-91.7
-68.6
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0008.6± 4.0
OG0010.8± 4.5
OG002-30.1± 4.1
OG003-23.3± 4.5
OG004-77.0± 2.9
OG005-75.1± 3.2
OG00612.7± 5.3
OG0077.0± 4.1
OG008-9.9± 5.2
OG009-19.5± 4.1
OG010-59.0± 3.7
OG011-54.8± 2.9
OG0127.8± 3.8
OG0132.4± 4.4
OG014-69.2± 2.7
OG015-73.3± 3.1
OG0165.1± 3.2
OG017-2.0± 4.7
OG018-52.1± 2.3
OG019-46.7± 3.3
OG020-4.5± 5.3
OG021-0.6± 6.6
OG022-83.5± 4.6
OG023-72.5± 5.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-85.5
Standard Error of the Mean
4.9
2-Sided
95
-95.2
-75.9
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-75.8
Standard Error of the Mean
5.5
2-Sided
95
-86.8
-64.9
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-46.8
Standard Error of the Mean
4.9
2-Sided
95
-56.6
-37.1
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-51.7
Standard Error of the Mean
5.5
2-Sided
95
-62.6
-40.9
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-71.7
Standard Error of the Mean
6.4
2-Sided
95
-84.4
-59.0
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-61.8
Standard Error of the Mean
5.0
2-Sided
95
-71.6
-52.0
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-49.0
Standard Error of the Mean
6.3
2-Sided
95
-61.5
-36.6
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-35.3
Standard Error of the Mean
5.0
2-Sided
95
-45.2
-25.5
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-77.1
Standard Error of the Mean
4.6
2-Sided
95
-86.2
-67.9
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-75.8
Standard Error of the Mean
5.3
2-Sided
95
-86.3
-65.3
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.2
Standard Error of the Mean
4.0
2-Sided
95
-65.1
-49.4
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.6
Standard Error of the Mean
5.7
2-Sided
95
-55.9
-33.4
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-79.0
Standard Error of the Mean
4.3
2-Sided
95
-87.5
-70.4
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-71.9
Standard Error of the Mean
6.0
2-Sided
95
-83.8
-60.0
Superiority or Other (legacy)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.80± 2.07
OG0011.28± 2.44
OG002-20.71± 2.15
OG003-16.56± 2.41
OG004-53.48± 1.48
OG005-56.09± 1.71
OG00610.74± 3.59
OG0078.45± 3.13
OG008-16.19± 3.49
OG009-18.79± 3.16
OG010-54.44± 2.49
OG011-56.31± 2.23
OG0127.02± 2.11
OG0133.73± 2.32
OG014-52.59± 1.54
OG015-55.47± 1.64
OG0166.19± 2.61
OG0171.58± 2.90
OG018-52.08± 1.88
OG019-55.72± 2.01
OG0200.74± 3.23
OG0216.81± 4.35
OG022-59.33± 2.79
OG023-56.01± 3.49
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.28
Standard Error of the Mean
2.54
2-Sided
95
-65.29
-55.27
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.37
Standard Error of the Mean
2.97
2-Sided
95
-63.23
-51.51
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.77
Standard Error of the Mean
2.57
2-Sided
95
-37.84
-27.70
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-39.53
Standard Error of the Mean
2.95
2-Sided
95
-45.34
-33.71
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-65.17
Standard Error of the Mean
4.37
2-Sided
95
-73.78
-56.56
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-64.76
Standard Error of the Mean
3.84
2-Sided
95
-72.32
-57.19
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-38.25
Standard Error of the Mean
4.28
2-Sided
95
-46.68
-29.81
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.52
Standard Error of the Mean
3.87
2-Sided
95
-45.15
-29.90
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.61
Standard Error of the Mean
2.60
2-Sided
95
-64.73
-54.48
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.20
Standard Error of the Mean
2.83
2-Sided
95
-64.80
-53.60
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-58.27
Standard Error of the Mean
3.20
2-Sided
95
-64.60
-51.94
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.31
Standard Error of the Mean
3.53
2-Sided
95
-64.29
-50.32
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.06
Standard Error of the Mean
2.59
2-Sided
95
-65.18
-54.94
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-62.82
Standard Error of the Mean
3.75
2-Sided
95
-70.22
-55.42
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0008.25± 2.32
OG0012.43± 2.69
OG002-18.27± 2.40
OG003-14.78± 2.65
OG004-53.39± 1.66
OG005-52.20± 1.90
OG00611.79± 3.87
OG0079.95± 3.51
OG008-14.34± 3.75
OG009-17.26± 3.52
OG010-54.84± 2.66
OG011-50.05± 2.50
OG0127.92± 2.40
OG0135.85± 2.42
OG014-52.04± 1.74
OG015-51.57± 1.72
OG0168.61± 3.04
OG0173.35± 3.53
OG018-50.97± 2.18
OG019-46.42± 2.45
OG0201.89± 3.38
OG0215.66± 4.53
OG022-59.02± 2.87
OG023-50.96± 3.60
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-61.64
Standard Error of the Mean
2.84
2-Sided
95
-67.25
-56.03
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.93
Standard Error of the Mean
3.28
2-Sided
95
-61.40
-48.46
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-35.11
Standard Error of the Mean
2.88
2-Sided
95
-40.79
-29.44
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.72
Standard Error of the Mean
3.26
2-Sided
95
-44.15
-31.30
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-66.64
Standard Error of the Mean
4.69
2-Sided
95
-75.88
-57.39
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.01
Standard Error of the Mean
4.30
2-Sided
95
-68.49
-51.52
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-40.51
Standard Error of the Mean
4.59
2-Sided
95
-49.55
-31.47
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.79
Standard Error of the Mean
4.32
2-Sided
95
-41.30
-24.28
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.96
Standard Error of the Mean
2.95
2-Sided
95
-65.78
-54.13
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.42
Standard Error of the Mean
2.96
2-Sided
95
-63.27
-51.57
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.58
Standard Error of the Mean
3.73
2-Sided
95
-66.95
-52.21
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-49.76
Standard Error of the Mean
4.30
2-Sided
95
-58.26
-41.27
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.91
Standard Error of the Mean
2.87
2-Sided
95
-66.57
-55.24
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.63
Standard Error of the Mean
4.06
2-Sided
95
-64.63
-48.62
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0007.55± 1.89
OG0010.81± 2.19
OG002-17.29± 2.00
OG003-11.43± 2.20
OG004-50.95± 1.38
OG005-51.44± 1.52
OG00610.20± 3.02
OG0075.48± 2.83
OG008-14.22± 2.98
OG009-13.62± 2.87
OG010-49.14± 2.13
OG011-53.26± 2.02
OG0125.07± 1.97
OG0132.54± 1.89
OG014-49.79± 1.46
OG015-53.59± 1.32
OG0163.71± 2.46
OG0171.98± 2.57
OG018-47.07± 1.76
OG019-52.95± 1.76
OG020-0.31± 3.02
OG0212.49± 4.67
OG022-55.65± 2.63
OG023-54.37± 3.93
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-58.49
Standard Error of the Mean
2.34
2-Sided
95
-63.10
-53.89
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-52.25
Standard Error of the Mean
2.66
2-Sided
95
-57.49
-47.01
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-33.66
Standard Error of the Mean
2.37
2-Sided
95
-38.33
-28.98
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-40.01
Standard Error of the Mean
2.67
2-Sided
95
-45.27
-34.74
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.34
Standard Error of the Mean
3.69
2-Sided
95
-66.61
-52.07
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-58.74
Standard Error of the Mean
3.46
2-Sided
95
-65.56
-51.93
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-34.92
Standard Error of the Mean
3.64
2-Sided
95
-42.09
-27.75
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-39.64
Standard Error of the Mean
3.52
2-Sided
95
-46.57
-32.71
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.86
Standard Error of the Mean
2.43
2-Sided
95
-59.66
-50.05
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.14
Standard Error of the Mean
2.29
2-Sided
95
-60.66
-51.61
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-50.78
Standard Error of the Mean
3.01
2-Sided
95
-56.72
-44.83
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.94
Standard Error of the Mean
3.12
2-Sided
95
-61.11
-48.76
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-55.34
Standard Error of the Mean
2.33
2-Sided
95
-59.94
-50.74
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.87
Standard Error of the Mean
3.24
2-Sided
95
-63.27
-50.46
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0007.89± 2.16
OG0010.21± 2.43
OG002-15.98± 2.26
OG003-10.95± 2.44
OG004-50.90± 1.56
OG005-47.15± 1.70
OG00611.64± 3.28
OG0076.54± 3.22
OG008-12.31± 3.20
OG009-12.16± 3.24
OG010-49.77± 2.28
OG011-46.47± 2.31
OG0126.35± 2.10
OG0134.63± 2.11
OG014-50.15± 1.54
OG015-48.58± 1.49
OG0164.91± 2.71
OG0173.24± 3.13
OG018-45.61± 1.93
OG019-43.71± 2.13
OG0200.35± 3.17
OG0213.57± 4.74
OG022-55.95± 2.72
OG023-49.16± 3.97
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-58.79
Standard Error of the Mean
2.66
2-Sided
95
-64.03
-53.55
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-47.36
Standard Error of the Mean
2.96
2-Sided
95
-53.20
-41.52
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-34.92
Standard Error of the Mean
2.69
2-Sided
95
-40.23
-29.60
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-36.21
Standard Error of the Mean
2.97
2-Sided
95
-42.06
-30.35
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-61.40
Standard Error of the Mean
3.99
2-Sided
95
-69.27
-53.54
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-53.01
Standard Error of the Mean
3.93
2-Sided
95
-60.77
-45.25
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.45
Standard Error of the Mean
3.91
2-Sided
95
-45.17
-29.74
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-34.31
Standard Error of the Mean
3.98
2-Sided
95
-42.15
-26.47
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.50
Standard Error of the Mean
2.58
2-Sided
95
-61.60
-51.40
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-53.21
Standard Error of the Mean
2.57
2-Sided
95
-58.29
-48.13
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-50.52
Standard Error of the Mean
3.31
2-Sided
95
-57.06
-43.99
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-46.95
Standard Error of the Mean
3.78
2-Sided
95
-54.43
-39.47
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.30
Standard Error of the Mean
2.61
2-Sided
95
-61.47
-51.14
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-52.73
Standard Error of the Mean
3.38
2-Sided
95
-59.40
-46.06
Superiority or Other (legacy)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0005.96± 1.76
OG0012.24± 2.11
OG002-14.39± 1.83
OG003-10.86± 2.08
OG004-40.44± 1.26
OG005-42.45± 1.48
OG0064.26± 2.59
OG0076.42± 2.34
OG008-11.92± 2.52
OG009-12.25± 2.35
OG010-40.22± 1.80
OG011-40.43± 1.66
OG0125.41± 1.96
OG0135.02± 2.25
OG014-39.33± 1.43
OG015-42.00± 1.59
OG0164.55± 1.98
OG0171.71± 2.36
OG018-36.04± 1.42
OG019-38.62± 1.64
OG020-0.14± 2.79
OG0215.45± 3.50
OG022-47.20± 2.37
OG023-43.17± 2.85
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-46.41
Standard Error of the Mean
2.16
2-Sided
95
-50.66
-42.15
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.69
Standard Error of the Mean
2.57
2-Sided
95
-49.75
-39.63
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-26.06
Standard Error of the Mean
2.19
2-Sided
95
-30.36
-21.75
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-31.59
Standard Error of the Mean
2.55
2-Sided
95
-36.61
-26.57
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.48
Standard Error of the Mean
3.15
2-Sided
95
-50.69
-38.27
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-46.85
Standard Error of the Mean
2.86
2-Sided
95
-52.48
-41.21
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.30
Standard Error of the Mean
3.09
2-Sided
95
-34.39
-22.21
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.18
Standard Error of the Mean
2.88
2-Sided
95
-33.86
-22.50
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.73
Standard Error of the Mean
2.41
2-Sided
95
-49.50
-39.97
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-47.01
Standard Error of the Mean
2.75
2-Sided
95
-52.46
-41.57
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-40.59
Standard Error of the Mean
2.43
2-Sided
95
-45.38
-35.79
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-40.33
Standard Error of the Mean
2.87
2-Sided
95
-46.00
-34.66
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-47.05
Standard Error of the Mean
2.38
2-Sided
95
-51.76
-42.35
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-48.62
Standard Error of the Mean
2.86
2-Sided
95
-54.27
-42.98
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.09± 2.02
OG0012.80± 2.31
OG002-12.14± 2.10
OG003-9.85± 2.28
OG004-40.74± 1.45
OG005-40.07± 1.63
OG0064.31± 2.75
OG0076.18± 2.73
OG008-10.53± 2.66
OG009-11.06± 2.73
OG010-40.79± 1.89
OG011-36.25± 1.94
OG0124.68± 2.28
OG0136.07± 2.36
OG014-38.57± 1.64
OG015-39.26± 1.68
OG0165.96± 2.28
OG0172.69± 2.80
OG018-35.17± 1.63
OG019-32.30± 1.94
OG020-0.20± 2.81
OG0215.13± 3.62
OG022-47.24± 2.38
OG023-39.47± 2.92
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-46.83
Standard Error of the Mean
2.48
2-Sided
95
-51.73
-41.94
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-42.86
Standard Error of the Mean
2.82
2-Sided
95
-48.43
-37.30
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.60
Standard Error of the Mean
2.51
2-Sided
95
-33.56
-23.65
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-30.22
Standard Error of the Mean
2.80
2-Sided
95
-35.74
-24.70
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-45.10
Standard Error of the Mean
3.33
2-Sided
95
-51.66
-38.54
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-42.43
Standard Error of the Mean
3.34
2-Sided
95
-49.01
-35.85
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-30.26
Standard Error of the Mean
3.26
2-Sided
95
-36.68
-23.84
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-25.19
Standard Error of the Mean
3.35
2-Sided
95
-31.79
-18.59
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-43.25
Standard Error of the Mean
2.79
2-Sided
95
-48.77
-37.74
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-45.33
Standard Error of the Mean
2.89
2-Sided
95
-51.04
-39.61
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-41.13
Standard Error of the Mean
2.79
2-Sided
95
-46.65
-35.61
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-34.99
Standard Error of the Mean
3.41
2-Sided
95
-41.72
-28.25
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-47.04
Standard Error of the Mean
2.43
2-Sided
95
-51.83
-42.25
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-44.60
Standard Error of the Mean
3.07
2-Sided
95
-50.67
-38.54
Superiority or Other (legacy)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.41± 2.03
OG0010.78± 2.29
OG002-15.77± 2.14
OG003-11.47± 2.29
OG004-53.56± 1.48
OG005-53.33± 1.58
OG0064.48± 3.04
OG0075.79± 2.79
OG008-15.17± 2.99
OG009-12.91± 2.80
OG010-52.43± 2.14
OG011-56.20± 1.98
OG0122.82± 2.26
OG0132.58± 2.05
OG014-52.46± 1.67
OG015-56.66± 1.43
OG0162.17± 2.56
OG0172.60± 2.97
OG018-48.47± 1.83
OG019-54.17± 2.04
OG020-1.00± 3.12
OG021-1.42± 4.22
OG022-58.76± 2.73
OG023-57.47± 3.55
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.97
Standard Error of the Mean
2.51
2-Sided
95
-64.91
-55.03
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.11
Standard Error of the Mean
2.77
2-Sided
95
-59.57
-48.64
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.79
Standard Error of the Mean
2.54
2-Sided
95
-42.80
-32.77
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-41.86
Standard Error of the Mean
2.78
2-Sided
95
-47.34
-36.67
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.90
Standard Error of the Mean
3.71
2-Sided
95
-64.22
-49.59
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-61.99
Standard Error of the Mean
3.39
2-Sided
95
-68.68
-55.29
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.26
Standard Error of the Mean
3.66
2-Sided
95
-44.48
-30.04
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-43.29
Standard Error of the Mean
3.44
2-Sided
95
-50.07
-36.51
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-55.29
Standard Error of the Mean
2.78
2-Sided
95
-60.79
-49.79
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-59.24
Standard Error of the Mean
2.49
2-Sided
95
-64.16
-54.32
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-50.63
Standard Error of the Mean
3.13
2-Sided
95
-56.82
-44.45
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.78
Standard Error of the Mean
3.61
2-Sided
95
-63.91
-49.64
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.75
Standard Error of the Mean
2.41
2-Sided
95
-62.51
-52.99
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.06
Standard Error of the Mean
2.93
2-Sided
95
-61.85
-50.27
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.13± 2.20
OG001-1.21± 2.41
OG002-14.51± 2.31
OG003-12.33± 2.41
OG004-54.17± 1.59
OG005-49.65± 1.69
OG0064.19± 3.25
OG0076.50± 3.18
OG008-13.69± 3.17
OG009-12.19± 3.17
OG010-53.59± 2.26
OG011-50.76± 2.26
OG0121.44± 2.30
OG0134.00± 2.27
OG014-52.97± 1.69
OG015-52.13± 1.60
OG0161.64± 2.75
OG0173.16± 3.51
OG018-47.53± 1.96
OG019-45.65± 2.39
OG020-1.80± 3.21
OG021-0.52± 4.29
OG022-59.53± 2.77
OG023-52.56± 3.59
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-60.29
Standard Error of the Mean
2.71
2-Sided
95
-65.65
-54.94
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-48.44
Standard Error of the Mean
2.94
2-Sided
95
-54.23
-42.65
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-39.66
Standard Error of the Mean
2.75
2-Sided
95
-45.09
-34.23
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.32
Standard Error of the Mean
2.94
2-Sided
95
-43.12
-31.52
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.77
Standard Error of the Mean
3.95
2-Sided
95
-65.55
-49.99
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.26
Standard Error of the Mean
3.88
2-Sided
95
-64.91
-49.60
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-39.90
Standard Error of the Mean
3.87
2-Sided
95
-47.53
-32.26
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-38.57
Standard Error of the Mean
3.90
2-Sided
95
-46.26
-30.88
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-54.41
Standard Error of the Mean
2.83
2-Sided
95
-59.99
-48.82
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-56.13
Standard Error of the Mean
2.76
2-Sided
95
-61.58
-50.68
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-49.17
Standard Error of the Mean
3.36
2-Sided
95
-55.80
-42.53
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-48.81
Standard Error of the Mean
4.25
2-Sided
95
-57.21
-40.40
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-57.73
Standard Error of the Mean
2.57
2-Sided
95
-62.82
-52.65
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-52.04
Standard Error of the Mean
3.07
2-Sided
95
-58.10
-45.98
Superiority or Other (legacy)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0005.7(1.9 to 15.4)
OG0015.6(1.9 to 15.1)
OG00220.0(11.2 to 33.0)
OG00316.7(9.0 to 28.7)
OG00488.1(80.7 to 92.9)
OG00585.8(78.0 to 91.2)
OG00613.7(6.8 to 25.7)
OG0079.3(4.0 to 19.9)
OG00850.9(38.1 to 63.6)
OG00962.3(48.8 to 74.1)
OG01094.4(88.4 to 97.4)
OG01192.5(85.9 to 96.2)
OG0127.0(2.8 to 16.7)
OG0135.3(1.8 to 14.4)
OG01488.7(81.2 to 93.4)
OG01589.9(82.8 to 94.3)
OG01638.9(27.0 to 52.2)
OG01728.8(18.3 to 42.3)
OG01893.5(87.1 to 96.8)
OG01994.5(88.6 to 97.5)
OG0201.9(0.3 to 9.8)
OG0213.9(1.1 to 13.2)
OG02293.6(87.3 to 96.9)
OG02388.5(81.3 to 93.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
82.4
2-Sided
95
70.2
88.5
Superiority or Other (legacy)
OG001
OG005
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
80.3
2-Sided
95
67.9
86.8
Superiority or Other (legacy)
OG002
OG004
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
68.1
2-Sided
95
53.1
78.1
Superiority or Other (legacy)
OG003
OG005
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
69.2
2-Sided
95
54.8
78.5
Superiority or Other (legacy)
OG006
OG010
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
80.7
2-Sided
95
67.3
88.3
Superiority or Other (legacy)
OG007
OG011
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
83.3
2-Sided
95
70.7
89.6
Superiority or Other (legacy)
OG008
OG010
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
43.5
2-Sided
95
29.5
56.7
Superiority or Other (legacy)
OG009
OG011
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
30.3
2-Sided
95
16.7
44.2
Superiority or Other (legacy)
OG012
OG014
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
81.7
2-Sided
95
69.5
88.0
Superiority or Other (legacy)
OG013
OG015
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
84.6
2-Sided
95
73.1
90.2
Superiority or Other (legacy)
OG016
OG018
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
54.6
2-Sided
95
39.8
66.9
Superiority or Other (legacy)
OG017
OG019
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
65.7
2-Sided
95
51.0
76.6
Superiority or Other (legacy)
OG020
OG022
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
91.7
2-Sided
95
81.6
95.3
Superiority or Other (legacy)
OG021
OG023
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
84.6
2-Sided
95
72.8
90.0
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0002.0(0.3 to 10.3)
OG0015.9(2.0 to 15.9)
OG00222.4(13.0 to 35.9)
OG00319.2(10.8 to 31.9)
OG00485.4(77.4 to 91.0)
OG00584.2(75.8 to 90.0)
OG00613.0(6.1 to 25.7)
OG0079.8(4.3 to 21.0)
OG00852.0(38.5 to 65.2)
OG00955.8(42.3 to 68.4)
OG01093.1(86.5 to 96.6)
OG01191.0(83.8 to 95.2)
OG0127.7(3.0 to 18.2)
OG0135.5(1.9 to 14.9)
OG01485.0(76.7 to 90.7)
OG01586.5(78.7 to 91.8)
OG01639.6(27.6 to 53.1)
OG01728.0(17.5 to 41.7)
OG01892.3(85.6 to 96.1)
OG01992.3(85.6 to 96.1)
OG0201.9(0.3 to 10.1)
OG0216.4(2.2 to 17.2)
OG02294.4(88.4 to 97.4)
OG02384.8(76.7 to 90.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
83.5
2-Sided
95
71.9
89.2
Superiority or Other (legacy)
OG001
OG005
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
78.3
2-Sided
95
65.2
85.3
Superiority or Other (legacy)
OG002
OG004
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
63.0
2-Sided
95
47.3
73.9
Superiority or Other (legacy)
OG003
OG005
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
64.9
2-Sided
95
49.8
75.2
Superiority or Other (legacy)
OG006
OG010
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
80.1
2-Sided
95
65.8
87.9
Superiority or Other (legacy)
OG007
OG011
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
81.2
2-Sided
95
67.9
88.1
Superiority or Other (legacy)
OG008
OG010
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
41.1
2-Sided
95
26.4
55.1
Superiority or Other (legacy)
OG009
OG011
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
35.2
2-Sided
95
20.7
49.3
Superiority or Other (legacy)
OG012
OG014
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
77.3
2-Sided
95
63.9
84.7
Superiority or Other (legacy)
OG013
OG015
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
81.1
2-Sided
95
68.8
87.5
Superiority or Other (legacy)
OG016
OG018
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
52.7
2-Sided
95
37.6
65.3
Superiority or Other (legacy)
OG017
OG019
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
64.3
2-Sided
95
49.1
75.5
Superiority or Other (legacy)
OG020
OG022
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
92.5
2-Sided
95
82.3
95.9
Superiority or Other (legacy)
OG021
OG023
Cochran-Mantel-Haenszel
Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Treatment Difference
78.4
2-Sided
95
64.9
85.4
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.07± 2.86
OG001-0.77± 3.28
OG0021.44± 3.02
OG0036.85± 3.29
OG004-26.01± 2.08
OG005-22.64± 2.27
OG006-3.45± 2.99
OG0071.51± 3.35
OG0088.05± 2.94
OG0099.96± 3.40
OG010-23.97± 2.10
OG011-27.46± 2.39
OG01211.41± 3.00
OG0133.65± 3.56
OG014-24.26± 2.21
OG015-23.16± 2.50
OG0168.59± 2.98
OG0176.26± 3.59
OG018-24.96± 2.12
OG019-25.93± 2.46
OG020-10.57± 4.49
OG021-4.99± 5.37
OG022-38.64± 3.92
OG023-32.16± 4.50
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.08
Standard Error of the Mean
3.54
2-Sided
95
-39.06
-25.11
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-21.86
Standard Error of the Mean
3.98
2-Sided
95
-29.70
-14.03
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-27.45
Standard Error of the Mean
3.59
2-Sided
95
-34.53
-20.38
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-29.49
Standard Error of the Mean
3.99
2-Sided
95
-37.36
-21.62
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-20.52
Standard Error of the Mean
3.65
2-Sided
95
-27.71
-13.33
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.96
Standard Error of the Mean
4.08
2-Sided
95
-37.01
-20.92
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.02
Standard Error of the Mean
3.60
2-Sided
95
-39.11
-24.93
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-37.42
Standard Error of the Mean
4.15
2-Sided
95
-45.61
-29.23
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-35.66
Standard Error of the Mean
3.69
2-Sided
95
-42.94
-28.38
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-26.81
Standard Error of the Mean
4.33
2-Sided
95
-35.36
-18.27
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-33.56
Standard Error of the Mean
3.64
2-Sided
95
-40.74
-26.37
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.19
Standard Error of the Mean
4.36
2-Sided
95
-40.80
-23.58
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.07
Standard Error of the Mean
3.46
2-Sided
95
-34.91
-21.23
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-27.16
Standard Error of the Mean
3.76
2-Sided
95
-34.59
-19.73
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0007.34± 3.13
OG001-0.43± 3.38
OG0023.29± 3.28
OG0037.18± 3.38
OG004-25.87± 2.26
OG005-20.25± 2.36
OG006-2.23± 3.35
OG0073.41± 3.54
OG0088.01± 3.26
OG00910.20± 3.57
OG010-24.61± 2.31
OG011-24.68± 2.53
OG01211.40± 3.37
OG0134.49± 3.68
OG014-25.09± 2.47
OG015-20.85± 2.59
OG01610.38± 3.09
OG01710.21± 4.36
OG018-26.11± 2.21
OG019-21.97± 2.97
OG020-6.81± 4.57
OG021-1.06± 5.67
OG022-38.06± 3.96
OG023-29.23± 4.68
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-33.20
Standard Error of the Mean
3.86
2-Sided
95
-40.81
-25.60
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-19.82
Standard Error of the Mean
4.11
2-Sided
95
-27.92
-11.72
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-29.16
Standard Error of the Mean
3.91
2-Sided
95
-36.87
-21.44
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-27.44
Standard Error of the Mean
4.12
2-Sided
95
-35.56
-19.32
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-22.38
Standard Error of the Mean
4.07
2-Sided
95
-30.39
-14.36
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.10
Standard Error of the Mean
4.32
2-Sided
95
-36.62
-19.58
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.62
Standard Error of the Mean
3.98
2-Sided
95
-40.46
-24.78
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-34.88
Standard Error of the Mean
4.38
2-Sided
95
-43.52
-26.25
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-36.50
Standard Error of the Mean
4.15
2-Sided
95
-44.69
-28.30
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-25.34
Standard Error of the Mean
4.48
2-Sided
95
-34.19
-16.49
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-36.48
Standard Error of the Mean
3.78
2-Sided
95
-43.95
-29.02
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.17
Standard Error of the Mean
5.28
2-Sided
95
-42.61
-21.74
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-31.25
Standard Error of the Mean
3.62
2-Sided
95
-38.40
-24.10
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-28.17
Standard Error of the Mean
4.36
2-Sided
95
-36.79
-19.55
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.49± 3.94
OG0019.17± 4.41
OG002-3.16± 4.10
OG0031.57± 4.35
OG004-5.61± 2.81
OG005-13.38± 3.08
OG0066.16± 4.02
OG0078.05± 4.35
OG008-8.10± 3.92
OG009-4.86± 4.39
OG010-9.27± 2.80
OG011-6.36± 3.11
OG01212.43± 4.19
OG01312.26± 4.67
OG014-10.28± 3.04
OG015-7.26± 3.29
OG0168.44± 3.76
OG01710.75± 3.98
OG018-9.15± 2.70
OG019-15.43± 2.77
OG0209.29± 6.97
OG02113.78± 7.44
OG022-11.67± 5.97
OG023-15.93± 6.15
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.20
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-12.10
Standard Error of the Mean
4.83
2-Sided
95
-21.63
-2.58
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-22.55
Standard Error of the Mean
5.36
2-Sided
95
-33.13
-11.97
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-2.45
Standard Error of the Mean
4.89
2-Sided
95
-12.09
7.19
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.053
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-14.95
Standard Error of the Mean
5.33
2-Sided
95
-25.46
-4.44
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.073
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-15.43
Standard Error of the Mean
4.89
2-Sided
95
-25.06
-5.79
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.027
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-14.41
Standard Error of the Mean
5.32
2-Sided
95
-24.90
-3.92
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-1.17
Standard Error of the Mean
4.80
2-Sided
95
-10.63
8.30
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.63
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-1.51
Standard Error of the Mean
5.38
2-Sided
95
-12.12
9.11
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-22.72
Standard Error of the Mean
5.15
2-Sided
95
-32.90
-12.54
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.007
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-19.52
Standard Error of the Mean
5.69
2-Sided
95
-30.76
-8.28
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.002
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-17.59
Standard Error of the Mean
4.62
2-Sided
95
-26.71
-8.46
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-26.18
Standard Error of the Mean
4.85
2-Sided
95
-35.76
-16.59
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-20.97
Standard Error of the Mean
5.78
2-Sided
95
-32.38
-9.55
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-29.71
Standard Error of the Mean
5.64
2-Sided
95
-40.84
-18.57
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0008.27± 5.23
OG00114.35± 5.92
OG002-0.43± 5.39
OG0034.88± 5.84
OG004-3.79± 3.72
OG005-13.26± 4.17
OG0066.65± 4.45
OG0078.22± 5.22
OG008-7.40± 4.32
OG009-3.11± 5.23
OG010-10.07± 3.05
OG011-1.10± 3.74
OG01213.57± 5.76
OG01312.96± 5.32
OG014-4.46± 4.16
OG015-6.88± 3.80
OG01610.97± 4.66
OG01710.00± 4.38
OG018-5.58± 3.34
OG019-10.51± 3.04
OG0208.07± 6.88
OG02116.72± 7.88
OG022-13.71± 5.91
OG023-14.65± 6.39
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.20
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-12.06
Standard Error of the Mean
6.41
2-Sided
95
-24.69
0.57
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-27.60
Standard Error of the Mean
7.23
2-Sided
95
-41.86
-13.35
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-3.37
Standard Error of the Mean
6.49
2-Sided
95
-16.16
9.43
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.053
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-18.13
Standard Error of the Mean
7.18
2-Sided
95
-32.28
-3.99
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.073
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-16.72
Standard Error of the Mean
5.39
2-Sided
95
-27.34
-6.10
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.027
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-9.31
Standard Error of the Mean
6.39
2-Sided
95
-21.92
3.29
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-2.67
Standard Error of the Mean
5.27
2-Sided
95
-13.05
7.72
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.63
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
2.02
Standard Error of the Mean
6.43
2-Sided
95
-10.66
14.69
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-18.03
Standard Error of the Mean
7.08
2-Sided
95
-32.03
-4.04
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.007
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-19.83
Standard Error of the Mean
6.52
2-Sided
95
-32.71
-6.96
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.002
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-16.55
Standard Error of the Mean
5.71
2-Sided
95
-27.84
-5.26
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-20.51
Standard Error of the Mean
5.33
2-Sided
95
-31.04
-9.98
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-21.78
Standard Error of the Mean
5.62
2-Sided
95
-32.88
-10.68
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-31.36
Standard Error of the Mean
6.45
2-Sided
95
-44.10
-18.62
Superiority or Other (legacy)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0006.51± 3.56
OG0019.53± 4.45
OG002-5.35± 3.74
OG0031.77± 4.41
OG004-6.85± 2.56
OG005-11.77± 3.11
OG0066.24± 4.03
OG0078.31± 4.26
OG008-8.52± 3.93
OG009-6.13± 4.31
OG010-8.96± 2.82
OG011-6.38± 3.05
OG01212.86± 3.95
OG01312.54± 4.58
OG014-12.22± 2.86
OG015-7.25± 3.23
OG0167.06± 3.76
OG0178.13± 3.72
OG018-9.09± 2.71
OG019-15.05± 2.58
OG0208.64± 6.01
OG02116.37± 7.15
OG022-14.57± 5.17
OG023-16.50± 5.87
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.088
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-13.36
Standard Error of the Mean
4.38
2-Sided
95
-21.99
-4.74
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.005
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-21.31
Standard Error of the Mean
5.41
2-Sided
95
-31.98
-10.64
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-1.50
Standard Error of the Mean
4.45
2-Sided
95
-10.27
7.27
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.056
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-13.54
Standard Error of the Mean
5.39
2-Sided
95
-24.17
-2.91
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.073
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-15.21
Standard Error of the Mean
4.91
2-Sided
95
-24.88
-5.54
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.027
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-14.69
Standard Error of the Mean
5.21
2-Sided
95
-24.97
-4.42
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-0.44
Standard Error of the Mean
4.82
2-Sided
95
-9.94
9.05
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.62
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-0.25
Standard Error of the Mean
5.28
2-Sided
95
-10.66
10.16
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-25.07
Standard Error of the Mean
4.85
2-Sided
95
-34.64
-15.50
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.007
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-19.79
Standard Error of the Mean
5.58
2-Sided
95
-30.81
-8.77
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.005
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-16.15
Standard Error of the Mean
4.61
2-Sided
95
-25.27
-7.03
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-23.18
Standard Error of the Mean
4.52
2-Sided
95
-32.11
-14.25
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-23.21
Standard Error of the Mean
4.95
2-Sided
95
-33.00
-13.43
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-32.87
Standard Error of the Mean
5.43
2-Sided
95
-43.60
-22.14
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0008.32± 4.00
OG00114.74± 5.91
OG002-4.61± 4.19
OG0033.45± 5.89
OG004-6.16± 2.88
OG005-11.73± 4.16
OG0066.73± 4.45
OG0078.54± 5.00
OG008-7.92± 4.32
OG009-6.00± 5.04
OG010-9.69± 3.05
OG011-1.06± 3.58
OG01213.79± 5.05
OG01312.47± 5.31
OG014-8.20± 3.64
OG015-6.28± 3.78
OG01610.09± 4.65
OG0178.59± 4.37
OG018-6.10± 3.33
OG019-9.95± 3.03
OG0207.63± 6.26
OG02120.97± 7.53
OG022-14.83± 5.30
OG023-15.86± 6.09
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.088
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-14.47
Standard Error of the Mean
4.92
2-Sided
95
-24.16
-4.78
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.005
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-26.47
Standard Error of the Mean
7.22
2-Sided
95
-40.71
-12.24
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-1.54
Standard Error of the Mean
5.00
2-Sided
95
-11.41
8.32
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.056
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-15.19
Standard Error of the Mean
7.21
2-Sided
95
-29.40
-0.97
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.073
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-16.42
Standard Error of the Mean
5.39
2-Sided
95
-27.05
-5.80
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.027
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-9.60
Standard Error of the Mean
6.13
2-Sided
95
-21.68
2.48
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
1.00
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-1.78
Standard Error of the Mean
5.27
2-Sided
95
-12.16
8.61
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.62
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
4.94
Standard Error of the Mean
6.18
2-Sided
95
-7.25
17.14
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-21.98
Standard Error of the Mean
6.20
2-Sided
95
-34.24
-9.73
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.007
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-18.75
Standard Error of the Mean
6.50
2-Sided
95
-31.60
-5.90
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.005
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-16.19
Standard Error of the Mean
5.70
2-Sided
95
-27.46
-4.92
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-18.54
Standard Error of the Mean
5.31
2-Sided
95
-29.04
-8.05
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-22.45
Standard Error of the Mean
5.39
2-Sided
95
-33.09
-11.81
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
-36.83
Standard Error of the Mean
6.14
2-Sided
95
-48.96
-24.70
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG000-0.99± 1.50
OG001-0.45± 1.94
OG002-1.13± 1.56
OG003-0.92± 1.92
OG0045.54± 1.07
OG0057.66± 1.37
OG0064.48± 1.73
OG007-1.37± 1.85
OG0080.86± 1.68
OG009-0.59± 1.86
OG0108.44± 1.20
OG0117.76± 1.31
OG0120.87± 1.52
OG013-0.94± 2.55
OG0146.23± 1.10
OG0157.72± 1.80
OG016-0.60± 1.56
OG017-0.40± 1.81
OG0184.86± 1.12
OG0196.35± 1.26
OG0200.13± 2.75
OG021-2.14± 2.72
OG02210.35± 2.26
OG0236.71± 2.25
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.034
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
6.53
Standard Error of the Mean
1.84
2-Sided
95
2.91
10.15
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.017
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.11
Standard Error of the Mean
2.37
2-Sided
95
3.43
12.79
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
6.67
Standard Error of the Mean
1.86
2-Sided
95
3.00
10.34
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.006
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.57
Standard Error of the Mean
2.36
2-Sided
95
3.93
13.22
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.85
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
3.95
Standard Error of the Mean
2.10
2-Sided
95
-0.19
8.09
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
9.13
Standard Error of the Mean
2.26
2-Sided
95
4.68
13.58
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
7.57
Standard Error of the Mean
2.06
2-Sided
95
3.51
11.64
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.35
Standard Error of the Mean
2.28
2-Sided
95
3.86
12.84
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
5.36
Standard Error of the Mean
1.87
2-Sided
95
1.68
9.04
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.010
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.66
Standard Error of the Mean
3.11
2-Sided
95
2.51
14.80
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.013
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
5.46
Standard Error of the Mean
1.91
2-Sided
95
1.69
9.23
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.002
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
6.75
Standard Error of the Mean
2.20
2-Sided
95
2.40
11.10
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
10.23
Standard Error of the Mean
2.58
2-Sided
95
5.13
15.32
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.85
Standard Error of the Mean
2.09
2-Sided
95
4.73
12.97
Superiority or Other (legacy)
OG004
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG005
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG006
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG007
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG008
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG009
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
OG010
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
OG011
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
OG012
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG013
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG014
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG015
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG016
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG017
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG018
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG019
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
OG020
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
OG021
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
OG022
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
OG023
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Units
Counts
Participants
OG00056
OG00155
OG00256
OG00355
OG004110
OG005110
OG00655
OG00755
OG00856
OG00954
OG010109
OG011110
OG01258
OG01357
OG014113
OG015115
OG01656
OG01755
OG018111
OG019112
OG02056
OG02155
OG022112
OG023115
Title
Denominators
Categories
Title
Measurements
OG0000.22± 1.72
OG0010.01± 2.02
OG002-1.76± 1.78
OG003-0.40± 1.99
OG0047.04± 1.23
OG0057.88± 1.42
OG0065.02± 1.88
OG0070.30± 2.01
OG0080.62± 1.83
OG0090.21± 2.01
OG0109.09± 1.29
OG0117.36± 1.43
OG0122.87± 1.87
OG013-0.16± 2.64
OG0146.07± 1.35
OG0157.18± 1.87
OG016-0.39± 1.86
OG0170.73± 1.98
OG0184.65± 1.34
OG0195.57± 1.37
OG0201.14± 2.96
OG021-2.65± 2.87
OG02210.92± 2.38
OG0236.41± 2.34
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.034
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
6.83
Standard Error of the Mean
2.11
2-Sided
95
2.66
10.99
Superiority or Other (legacy)
OG001
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.017
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
7.87
Standard Error of the Mean
2.46
2-Sided
95
3.01
12.73
Superiority or Other (legacy)
OG002
OG004
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.81
Standard Error of the Mean
2.14
2-Sided
95
4.58
13.03
Superiority or Other (legacy)
OG003
OG005
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.006
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.28
Standard Error of the Mean
2.45
2-Sided
95
3.46
13.11
Superiority or Other (legacy)
OG006
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.85
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
4.07
Standard Error of the Mean
2.28
2-Sided
95
-0.42
8.57
Superiority or Other (legacy)
OG007
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
7.05
Standard Error of the Mean
2.45
2-Sided
95
2.22
11.89
Superiority or Other (legacy)
OG008
OG010
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
8.47
Standard Error of the Mean
2.23
2-Sided
95
4.07
12.87
Superiority or Other (legacy)
OG009
OG011
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.003
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
7.14
Standard Error of the Mean
2.46
2-Sided
95
2.29
11.99
Superiority or Other (legacy)
OG012
OG014
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
3.20
Standard Error of the Mean
2.30
2-Sided
95
-1.33
7.73
Superiority or Other (legacy)
OG013
OG015
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.010
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
7.35
Standard Error of the Mean
3.23
2-Sided
95
0.97
13.72
Superiority or Other (legacy)
OG016
OG018
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.013
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
5.04
Standard Error of the Mean
2.29
2-Sided
95
0.52
9.56
Superiority or Other (legacy)
OG017
OG019
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
0.002
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
4.84
Standard Error of the Mean
2.41
2-Sided
95
0.07
9.60
Superiority or Other (legacy)
OG020
OG022
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
LS Mean Treatment Difference
9.78
Standard Error of the Mean
2.90
2-Sided
95
4.05
15.51
Superiority or Other (legacy)
OG021
OG023
Repeated measures linear effects model
The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit
<0.001
Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.