Phase III Study To Evaluate Alirocumab in Patients With H... | NCT02023879 | Trialant
NCT02023879
Sponsor
Sanofi
Status
Completed
Last Update Posted
Jul 27, 2018Actual
Enrollment
233Actual
Phase
Phase 3
Conditions
Hypercholesterolemia
Interventions
Alirocumab
Placebo (for Alirocumab)
Non-statin LMT
Diet Alone
Countries
United States
Australia
Belgium
Canada
Denmark
Netherlands
New Zealand
Spain
Protocol Section
Identification Module
NCT ID
NCT02023879
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EFC13786
Secondary IDs
ID
Type
Description
Link
2013-002659-14
EudraCT Number
U1111-1146-3517
Other Identifier
UTN
Brief Title
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Jun 2018
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
Dec 16, 2013
Primary Completion Date
Oct 27, 2014Actual
Completion Date
Jun 30, 2017Actual
First Submitted Date
Dec 6, 2013
First Submission Date that Met QC Criteria
Dec 24, 2013
First Posted Date
Dec 30, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 24, 2017
Results First Submitted that Met QC Criteria
Jan 24, 2017
Results First Posted Date
Mar 15, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 8, 2015
Certification/Extension First Submitted that Passed QC Review
Oct 8, 2015
Certification/Extension First Posted Date
Nov 2, 2015Estimated
Last Update Submitted Date
Jun 29, 2018
Last Update Posted Date
Jul 27, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Regeneron Pharmaceuticals
INDUSTRY
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
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin.
Secondary Objective:
To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo.
To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.
Alirocumab 75 mg Q2W was added as a calibrator arm.
Detailed Description
The core study duration was approximately 35 weeks per participant (screening: 3 weeks, double-blind treatment period: 24 weeks; follow-up: 8 weeks). Participants who successfully completed the treatment period had the possibility to participate in an optional open-label treatment period with Alirocumab 150 mg Q4W until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first.
Conditions Module
Conditions
Hypercholesterolemia
Keywords
Not provided
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
233Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo Q2W
Placebo Comparator
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
Drug: Alirocumab
Drug: Placebo (for Alirocumab)
Drug: Non-statin LMT
Other: Diet Alone
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Other
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
Drug: Alirocumab
Drug: Non-statin LMT
Other: Diet Alone
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Experimental
Period 1: Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Alirocumab
Drug
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
From Baseline to Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
From Baseline to Week 24
Other Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Mean percent changes (and standard deviations) observed during the open-label extension period are provided.
Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or fenofibrate) or diet alone.
Exclusion criteria:
LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very high cardiovascular (CV) risk;
LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at high or moderate CV risk or, participants not fulfilling the statin intolerant definition at moderate CV risk;
LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or, participants not fulfilling the statin intolerant definition at moderate CV risk and receiving a non-statin LMT.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Stroes E, Guyton JR, Lepor N, Civeira F, Gaudet D, Watts GF, Baccara-Dinet MT, Lecorps G, Manvelian G, Farnier M; ODYSSEY CHOICE II Investigators. Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study. J Am Heart Assoc. 2016 Sep 13;5(9):e003421. doi: 10.1161/JAHA.116.003421.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Randomization was stratified by statin intolerant status & background therapy (non-statin lipid therapy vs diet). Randomization followed a 1:2:1 ratio for placebo, Alirocumab 75 mg and Alirocumab 150 mg instead of 1:1:2 as initially planned due to systematic error in treatment allocation algorithm discovered after all participants were randomized.
Recruitment Details
The study was conducted at 43 centers in 8 countries. A total of 402 participants were screened between December-2013 and May-2014, of whom 233 were randomized for double-blind (DB) treatment period and 169 were screen failures. Out of 233 randomized for DB period, 205 participants entered the optional open-label (OL) extension period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Q2W
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
Periods
Title
Milestones
Reasons Not Completed
Period 1: 24-Week Double-blind Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A double-blind treatment period of 24 weeks (3 parallel arms) followed by an open-label extension period (single arm)
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Masking during the double-blind treatment period
Who Masked
ParticipantCare ProviderInvestigator
Drug: Alirocumab
Drug: Placebo (for Alirocumab)
Drug: Non-statin LMT
Other: Diet Alone
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Placebo Q2W
SAR236553
REGN727
Praluent®
Placebo (for Alirocumab)
Drug
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Placebo Q2W
Non-statin LMT
Drug
Ezetimibe or Fenofibrate at stable dose as background therapy.
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Placebo Q2W
Diet Alone
Other
Stable cholesterol-lowering diet as background therapy.
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Placebo Q2W
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
From Baseline to Week 24
Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
From Baseline to Week 24
Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
From Baseline to Week 24
Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
From Baseline to Week 24
Percent Change From Baseline in Total-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis
High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.
Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included.
From Baseline to Week 24
Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
From Baseline to Week 24
Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
From Baseline to Week 24
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis
Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
From Baseline to Week 24
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
From Baseline to Week 24
Atlantis
Florida
33462
United States
Investigational Site Number 840708
Jacksonville
Florida
32216
United States
Investigational Site Number 840701
Sarasota
Florida
34239
United States
Investigational Site Number 840706
Fall River
Massachusetts
02720
United States
Investigational Site Number 840705
St Louis
Missouri
63131
United States
Investigational Site Number 840707
Durham
North Carolina
27710
United States
Investigational Site Number 840702
Summerville
South Carolina
29485
United States
Investigational Site Number 036703
Ashford
5035
Australia
Investigational Site Number 036702
Perth
6000
Australia
Investigational Site Number 036701
Woolloongabba
4102
Australia
Investigational Site Number 056702
Antwerp
2060
Belgium
Investigational Site Number 056703
Haine-Saint-Paul
7100
Belgium
Investigational Site Number 056701
Leuven
3000
Belgium
Investigational Site Number 124703
Chicoutimi
G7H 7P2
Canada
Investigational Site Number 124701
Québec
G1V 4M6
Canada
Investigational Site Number 124704
Sherbrooke
J1H 1Z1
Canada
Investigational Site Number 124706
Toronto
M9V 4B4
Canada
Investigational Site Number 124702
Vancouver
V5Z 1M9
Canada
Investigational Site Number 124705
Victoria
V8T 5G4
Canada
Investigational Site Number 208703
Aarhus
8200
Denmark
Investigational Site Number 208702
Esbjerg
6700
Denmark
Investigational Site Number 208701
Glostrup Municipality
2600
Denmark
Investigational Site Number 208704
Hvidovre
2650
Denmark
Investigational Site Number 208705
Køge
4600
Denmark
Investigational Site Number 528701
Amsterdam
1105 AZ
Netherlands
Investigational Site Number 528708
Den Helder
1782 GZ
Netherlands
Investigational Site Number 528702
Hoogeveen
7909 AA
Netherlands
Investigational Site Number 528703
Hoorn
1625 HV
Netherlands
Investigational Site Number 528706
Rotterdam
3045 PM
Netherlands
Investigational Site Number 528709
Sneek
8601 ZK
Netherlands
Investigational Site Number 528704
Utrecht
3584 CX
Netherlands
Investigational Site Number 528707
Venlo
5912 BL
Netherlands
Investigational Site Number 554702
Auckland
1023
New Zealand
Investigational Site Number 554701
Christchurch
8011
New Zealand
Investigational Site Number 724703
A Coruña
15006
Spain
Investigational Site Number 724707
Barcelona
08025
Spain
Investigational Site Number 724710
Barcelona
08035
Spain
Investigational Site Number 724702
Córdoba
14004
Spain
Investigational Site Number 724705
Granada
18012
Spain
Investigational Site Number 724709
Sant Joan Despí
08970
Spain
Investigational Site Number 724706
Santiago de Compostela
15706
Spain
Investigational Site Number 724701
Zaragoza
50009
Spain
FG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
FG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
FG00058 subjects
FG001116 subjects
FG00259 subjects
Treated
FG00058 subjects
FG001115 subjects
FG00258 subjects
COMPLETED
FG00054 subjects
FG001107 subjects
FG00250 subjects
NOT COMPLETED
FG0004 subjects
FG0019 subjects
FG0029 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0025 subjects
Poor compliance to protocol
FG0000 subjects
FG0012 subjects
FG0021 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
Consent withdrawn by participant
FG0001 subjects
FG0010 subjects
FG0021 subjects
Randomized but not treated
FG0000 subjects
FG0011 subjects
FG0021 subjects
Other than specified above
FG0001 subjects
FG0013 subjects
FG0021 subjects
Extension Open Label Treatment
Type
Comment
Milestone Data
STARTED
FG00051 subjectsThe open-label extension period was optional for participants who completed the double-blind period.
FG001106 subjectsThe open-label extension period was optional for participants who completed the double-blind period.
FG00248 subjectsThe open-label extension period was optional for participants who completed the double-blind period.
COMPLETED
FG00046 subjects
FG00189 subjects
FG00243 subjects
NOT COMPLETED
FG0005 subjects
FG00117 subjects
FG0025 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0017 subjects
FG0023 subjects
Poor compliance to protocol
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Q2W
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
BG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
BG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG001116
BG00259
BG003233
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
BG00063.1± 10.7
BG00162.5± 9.9
BG00264.2± 10.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00147
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Calculated LDL-C in mg/dL
Calculated LDL-C from Friedewald formula (LDL-C = Total cholesterol [Total-C] - High-Density Lipoprotein Cholesterol [HDL-C] - [Triglyceride/5]).
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000158.5± 47.3
BG001
Calculated LDL-C in mmol/L
Mean
Standard Deviation
mmol/L
Title
Denominators
Categories
Title
Measurements
BG0004.106± 1.226
BG0014.002± 1.154
BG002
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 Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0004.7± 2.3
OG001-53.5± 1.6
OG002-51.7± 2.3
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
OG002
Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
Least square (LS) mean difference
-56.4
2-Sided
95
-62.9
-49.9
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Secondary
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Secondary
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
mITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Total-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis
High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.
Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included.
ITT population.
Posted
Number
percentage of participants
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Secondary
Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population.
Posted
Number
percentage of participants
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population.
Posted
Number
percentage of participants
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis
Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population.
Posted
Number
percentage of participants
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population.
Posted
Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population.
Posted
Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Secondary
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.
Posted
Least Squares Mean
Standard Error
percent change
From Baseline to Week 24
ID
Title
Description
OG000
Placebo Q2W
Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
OG001
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Other Pre-specified
Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase
Mean percent changes (and standard deviations) observed during the open-label extension period are provided.
Open-label extension population included all participants who received at least one dose or part of dose of Alirocumab during the open label extension period. Here, "number analyzed" signifies the number of participants evaluable for each specified time-point.
Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received placebo (for Alirocumab) Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
Time Frame
All Adverse Events (AE) were collected from signature of informed consent form up to study completion (up to 176 weeks) regardless of seriousness or relationship to investigational product.
Description
Reported AEs/deaths are treatment-emergent ie; AEs that developed/worsened and deaths that occurred 'on treatment'; from 1st dose up to last dose (active/placebo depending on Q2W/Q4W dosing) in DB period+70 days, truncated at the day before 1st dose in OL period for participants entering in OL period; from 1st dose up to last dose in OL period+70 days.
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
Placebo Q2W
Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
0
58
4
58
28
58
EG001
Alirocumab 75 mg Q2W/Up150 mg Q2W
Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
0
115
7
115
61
115
EG002
Alirocumab 150 mg Q4W/Up150 mg Q2W
Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
0
58
7
58
29
58
EG003
Alirocumab 150 mg Q4W (After Placebo Q2W)
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 128 weeks) after having received Placebo Q2W for 24 weeks.
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 117 weeks) after having received Alirocumab 75 mg Q2W/Up to 150 mg Q2W for 24 weeks.
Participants exposed to alirocumab 150 mg Q4W SC injection added to stable non-statin LMT or diet alone (mean exposure of 119 weeks) after having received Alirocumab 150 mg Q4W/Up to 150 mg Q2W for 24 weeks.
1
48
14
48
31
48
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG0030 affected51 at risk
EG0040 affected106 at risk
EG0050 affected48 at risk
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Traumatic renal injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Benign fallopian tube neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Arachnoiditis
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected58 at risk
EG0015 affected115 at risk
EG0021 affected58 at risk
EG0033 affected51 at risk
EG00411 affected106 at risk
EG0052 affected48 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected58 at risk
EG0016 affected115 at risk
EG0023 affected58 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0015 affected115 at risk
EG0024 affected58 at risk
EG003
Injection site reaction
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0014 affected115 at risk
EG0028 affected58 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected58 at risk
EG0013 affected115 at risk
EG0020 affected58 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected58 at risk
EG0013 affected115 at risk
EG0020 affected58 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0021 affected58 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected115 at risk
EG0021 affected58 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0011 affected115 at risk
EG0020 affected58 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 affected58 at risk
EG0014 affected115 at risk
EG0023 affected58 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0014 affected115 at risk
EG0024 affected58 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected58 at risk
EG00110 affected115 at risk
EG0025 affected58 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0016 affected115 at risk
EG0020 affected58 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected58 at risk
EG0018 affected115 at risk
EG0027 affected58 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0015 affected115 at risk
EG0022 affected58 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0019 affected115 at risk
EG0023 affected58 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0013 affected115 at risk
EG0020 affected58 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected58 at risk
EG0017 affected115 at risk
EG0023 affected58 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0012 affected115 at risk
EG0020 affected58 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected58 at risk
EG0010 affected115 at risk
EG0020 affected58 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected58 at risk
EG0014 affected115 at risk
EG0023 affected58 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected58 at risk
EG0011 affected115 at risk
EG0024 affected58 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected58 at risk
EG00110 affected115 at risk
EG0025 affected58 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0012 affected115 at risk
EG0021 affected58 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected115 at risk
EG0021 affected58 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected115 at risk
EG0021 affected58 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected115 at risk
EG0023 affected58 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected58 at risk
EG0011 affected115 at risk
EG0022 affected58 at risk
EG003
The systematic randomization error was not anticipated to have an impact on the power of the study. The sample size to detect a difference in efficacy endpoints was reached (it was increased to obtain additional safety data) and blind was maintained.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Trial Transparency Team
Sanofi
Contact-US@sanofi.com
ID
Term
D006937
Hypercholesterolemia
Ancestor Terms
ID
Term
D006949
Hyperlipidemias
D050171
Dyslipidemias
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C571059
alirocumab
D004032
Diet
Ancestor Terms
ID
Term
D009747
Nutritional Physiological Phenomena
D000066888
Diet, Food, and Nutrition
D010829
Physiological Phenomena
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0011 subjects
FG0020 subjects
Participant moved
FG0001 subjects
FG0012 subjects
FG0020 subjects
Other than specified above
FG0002 subjects
FG0017 subjects
FG0022 subjects
63.1
± 10.1
29
BG003103
Male
BG00031
BG00169
BG00230
BG003130
4
BG00312
Not Hispanic or Latino
BG00057
BG001109
BG00254
BG003220
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
0
BG0030
Asian
BG0001
BG0014
BG0023
BG0038
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0031
Black or African American
BG0001
BG0013
BG0021
BG0035
White
BG00056
BG001108
BG00255
BG003219
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
154.5
± 44.6
BG002163.9± 69.1
BG003157.9± 52.4
4.245
± 1.789
BG0034.089± 1.356
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0005.1± 2.1
OG001-55.3± 1.5
OG002-54.6± 2.1
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
OG002
A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-59.7
2-Sided
95
-65.6
-53.8
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0003.2± 2.5
OG001-50.8± 1.7
OG002-41.7± 2.4
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-44.9
2-Sided
95
-51.8
-38.1
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0003.6± 2.3
OG001-51.5± 1.6
OG002-44.8± 2.3
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-48.4
2-Sided
95
-54.8
-41.9
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0003.2± 2.0
OG001-53.6± 1.4
OG002-52.3± 2.0
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-55.5
2-Sided
95
-61.1
-49.8
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0003.6± 1.9
OG001-54.1± 1.3
OG002-55.0± 1.9
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-58.6
2-Sided
95
-63.8
-53.4
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001112
OG00258
Title
Denominators
Categories
Title
Measurements
OG0007.5± 2.1
OG001-39.7± 1.5
OG002-38.9± 2.2
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-46.4
2-Sided
95
-52.4
-40.4
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00054
OG001112
OG00254
Title
Denominators
Categories
Title
Measurements
OG0007.7± 2.0
OG001-41.2± 1.4
OG002-40.9± 2.1
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-48.6
2-Sided
95
-54.3
-42.8
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0004.8± 2.1
OG001-45.3± 1.5
OG002-44.2± 2.1
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-49.0
2-Sided
95
-54.9
-43.2
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0005.0± 1.9
OG001-46.9± 1.3
OG002-46.7± 1.9
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-51.7
2-Sided
95
-57.1
-46.4
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0003.0± 1.6
OG001-34.0± 1.1
OG002-32.3± 1.6
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-35.3
2-Sided
95
-39.8
-30.8
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001112
OG00258
Title
Denominators
Categories
Title
Measurements
OG0007.0± 2.2
OG001-38.4± 1.6
OG002-31.3± 2.2
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-38.2
2-Sided
95
-44.3
-32.1
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0003.0± 2.2
OG001-43.4± 1.5
OG002-34.9± 2.2
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-37.9
2-Sided
95
-43.9
-31.8
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0001.8± 1.6
OG001-32.6± 1.2
OG002-24.5± 1.6
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Mixed Models Analysis
<0.0001
Threshold for significance at 0.05 level.
LS Mean Difference
-26.3
2-Sided
95
-30.9
-21.7
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
OG002
Alirocumab 150 mg Q4W/Up to 150 mg Q2W
Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0001.8
OG00170.3
OG00263.9
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Logistic
Multiple imputation approach followed by logistic regression model.
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
279.8
2-Sided
95
29.1
2690.1
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0001.8
OG00172.7
OG00267.7
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Logistic
Multiple imputation approach followed by logistic regression model.
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
354.7
2-Sided
95
36.2
3479.5
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00160.0
OG00250.0
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Logistic
LOCF approach followed by logistic regression model.
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
126.0
2-Sided
95
20.0
9999
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to >9999)
Superiority or Other
Units
Counts
Participants
OG00056
OG001115
OG00257
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00161.7
OG00250.9
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Logistic
LOCF approach followed by logistic regression model.
<0.0001
Threshold for significance at 0.05 level.
Odds Ratio (OR)
141.5
2-Sided
95
22.2
9999
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to >9999)
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0004.1± 3.7
OG001-21.8± 2.6
OG002-15.5± 3.7
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Robust
Multiple imputation approach followed by robust regression model.
0.0002
Threshold for significance at 0.05 level.
Adjusted mean difference
-19.6
2-Sided
95
-29.8
-9.4
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Superiority or Other
Units
Counts
Participants
OG00057
OG001115
OG00258
Title
Denominators
Categories
Title
Measurements
OG0002.2± 3.4
OG001-16.5± 2.4
OG002-5.7± 3.3
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
OG002
Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Regression, Robust
Multiple imputation approach followed by robust regression model.
0.0892
Threshold for significance at 0.05 level.
Adjusted mean difference
-7.9
2-Sided
95
-17.1
1.2
Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo
Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first, in participants who received 150 mg Q4W/Up to 150 mg Q2W for 24 weeks during the double-blind period. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.