MK0653C in High Cardiovascular Risk Patients With High Ch... | NCT01154036 | Trialant
NCT01154036
Sponsor
Organon and Co
Status
Completed
Last Update Posted
Feb 9, 2022Actual
Enrollment
1,547Actual
Phase
Phase 3
Conditions
Hypercholesterolemia
Interventions
ezetimibe 10 mg
atorvastatin
Comparator: rosuvastatin
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT01154036
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0653C-162
Secondary IDs
ID
Type
Description
Link
2010_517
Other Identifier
Merck Study Number
Brief Title
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Official Title
A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin
Acronym
Not provided
Organization
Organon and CoINDUSTRY
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2010
Primary Completion Date
Sep 2012Actual
Completion Date
Oct 2012Actual
First Submitted Date
Jun 29, 2010
First Submission Date that Met QC Criteria
Jun 29, 2010
First Posted Date
Jun 30, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 5, 2013
Results First Submitted that Met QC Criteria
Dec 23, 2013
Results First Posted Date
Feb 12, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 7, 2022
Last Update Posted Date
Feb 9, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Organon and CoINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Detailed Description
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Drug: ezetimibe 10 mg
Drug: atorvastatin
Phase I: Atorvastatin 20 mg
Active Comparator
Atorvastatin 20 mg tablet once daily for 6 weeks
Drug: atorvastatin
Phase I: Rosuvastatin 10 mg
Active Comparator
Rosuvastatin 10 mg tablet once daily for 6 weeks
Drug: Comparator: rosuvastatin
Phase II: EZ 10mg+Atorva 10mg
Experimental
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I
Drug: ezetimibe 10 mg
Drug: atorvastatin
Phase II: EZ 10mg + Atorva 20mg [A]
Experimental
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
Baseline and Week 6 (end of Phase I )
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
Patient is willing to maintain a cholesterol lowering diet during the study
Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion Criteria:
Patient is Asian
Patient routinely has more than 2 alcoholic drinks per day
Female patient is pregnant or breastfeeding
Patient has congestive heart failure
Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
Patient has uncontrolled cardiac arrhythmias
Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
Patient has uncontrolled high blood pressure
Patient has kidney disease
Patient has any disease known to influence blood lipid levels
Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
Patient has poorly controlled or newly diagnosed diabetes
Patient is known to be HIV positive
Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.
Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Participants in the Atorvastatin 20mg and Rosuvastatin 10mg arms who did not meet low density lipoprotein-cholesterol goals during Phase I were eligible for Phase II. Approximately 25% of participants in the ezetimibe 10mg+atorvastatin10mg arm continued to Phase II regardless of LDL-C control but were not included in any of the statistical analyses
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
FG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
FG002
Phase I: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
FG003
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
FG004
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
FG005
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
FG006
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
FG007
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
Periods
Title
Milestones
Reasons Not Completed
Phase I
Type
Comment
Milestone Data
STARTED
FG000120 subjects
FG001483 subjects
FG002944 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000117 subjectsNot all completers were eligible for Phase II
FG001455 subjectsNot all completers were eligible for Phase II
FG002888 subjectsNot all completers were eligible for Phase II
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
BG001
Phase I: Atorvastatin 20 mg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Adverse Events Module
Frequency Threshold
5
Time Frame
up to 12 weeks
Description
Adverse events were reported using the All Patients as Treated (APaT) Population, which was defined as all randomized participants who received at least 1 dose of study drug.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Argentina
Belgium
Bulgaria
Canada
Chile
Colombia
Croatia
Czechia
Denmark
Estonia
Finland
France
Germany
Hungary
Israel
Italy
Lithuania
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Turkey (Türkiye)
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006937
Hypercholesterolemia
Ancestor Terms
ID
Term
D006949
Hyperlipidemias
D050171
Dyslipidemias
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000069438
Ezetimibe
D000069059
Atorvastatin
Ancestor Terms
ID
Term
D001384
Azetidines
D001385
Azetines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: ezetimibe 10 mg
Drug: atorvastatin
Phase II: Atorva 40mg
Active Comparator
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
Drug: atorvastatin
Phase II: EZ 10mg + Atorva 20mg [R]
Experimental
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
Drug: ezetimibe 10 mg
Drug: atorvastatin
Phase II: Rosuvastatin 20mg
Active Comparator
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Week 12 (End of Phase II)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Week 12 (end of Phase II)
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Triglycerides (TG) (Phase I)
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Triglycerides (TG) (Phase II)
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in HDL-C (Phase II)
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B (Phase II)
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo A-I (Phase II)
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C (Phase I)
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C (Phase II)
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Hs-CRP (Phase II)
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0013 subjects
FG0029 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0002 subjects
FG00110 subjects
FG00229 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0001 subjects
FG00111 subjects
FG00212 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
28 subjects
Only participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II
FG004124 subjectsOnly participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II
FG005126 subjectsOnly participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II
FG006234 subjectsOnly participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II
FG007206 subjectsOnly participants who did not meet LDL-C goals at the end of Phase I, were eligible for Phase II
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00327 subjects
FG004116 subjects
FG005121 subjects
FG006225 subjects
FG007200 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0048 subjects
FG0055 subjects
FG0069 subjects
FG0076 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Atorvastatin 20 mg tablet once daily for 6 weeks
BG002
Phase I: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks
BG003
Total
Total of all reporting groups
120
BG001483
BG002944
BG0031547
Participants
Title
Denominators
Categories
<20 years
Title
Measurements
BG0000
BG0010
BG0021
BG0031
20 to 29 years
Title
Measurements
BG0000
BG0014
BG0022
BG003
30 to 39 years
Title
Measurements
BG0001
BG00113
BG00225
BG003
40 to 49 years
Title
Measurements
BG00016
BG00150
BG00299
BG003
50 to 59 years
Title
Measurements
BG00037
BG001170
BG002324
BG003
60 to 64 years
Title
Measurements
BG00027
BG00187
BG002183
BG003
≥65 years
Title
Measurements
BG00039
BG001159
BG002310
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00071
BG001253
BG002489
BG003813
Male
BG00049
BG001230
BG002455
BG003734
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Phase I: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-24.8± 23.6
OG001-10.1± 20.8
OG002-13.8± 22.8
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
The primary hypotheses were tested at 0.045, applying Hochberg's procedure.
Difference in M-estimates
-12.7
2-Sided
95
-16.6
-8.7
Superiority or Other (legacy)
OG000
OG002
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
The primary hypotheses were tested at 0.045, applying Hochberg's procedure.
Difference in M-estimate
-9.1
2-Sided
95
-12.9
-5.4
Superiority or Other (legacy)
Secondary
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6) and Week 12
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-16.4± 31.1
OG001-8.1± 23.3
OG002-19.3± 32.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.
Difference in M-estimates
-10.5
2-Sided
95
-15.9
-5.1
Superiority or Other (legacy)
Secondary
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000119
OG001471
OG002915
Title
Denominators
Categories
Title
Measurements
OG00056.3± 4.55
OG00137.4± 2.23
OG00243.6± 1.64
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
OG001
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
2.51
2-Sided
95
1.62
3.89
Superiority or Other (legacy)
OG000
OG002
Secondary
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II
Posted
Number
Percentage of Participants
Week 12 (End of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000120
OG001123
OG002228
OG003
Title
Denominators
Categories
Title
Measurements
OG00055.8± 4.53
OG00134.1± 4.28
OG00253.5± 3.30
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Logistic regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
2.71
2-Sided
95
1.55
4.73
Superiority or Other (legacy)
OG002
OG003
Secondary
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000119
OG001471
OG002915
Title
Denominators
Categories
Title
Measurements
OG00019.3± 3.62
OG0013.0± 0.78
OG0026.6± 0.82
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
OG001
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
9.46
2-Sided
95
4.56
19.62
Superiority or Other (legacy)
OG000
OG002
Secondary
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II
Posted
Number
Percentage of Participants
Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000120
OG001123
OG002228
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.3± 3.53
OG0010.8± 0.81
OG00215.4± 2.39
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
0.001
Odds Ratio (OR)
27.77
2-Sided
95
3.64
211.83
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-13.6± 17.0
OG001-6.3± 14.1
OG002-8.2± 14.7
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-7.1
2-Sided
95
-9.7
-4.4
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-10.2± 19.9
OG001-2.9± 15.7
OG002-13.1± 22.8
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-6.8
2-Sided
95
-10.7
-3.0
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Triglycerides (TG) (Phase I)
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000119
OG001471
OG002915
Title
Denominators
Categories
Title
Measurements
OG000-6.0(-10.9 to -0.8)
OG001-3.9(-6.5 to -1.2)
OG002-1.1(-3.1 to 0.9)
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
OG001
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.466
Difference in least-squares means
-2.1
2-Sided
95
-7.8
3.5
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Triglycerides (TG) (Phase II)
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000120
OG001123
OG002228
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.9(-11.0 to -0.4)
OG001-3.1(-8.4 to 2.4)
OG002-10.2(-13.9 to -6.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.466
Difference in Least-squares Means
-2.8
2-Sided
95
-10.2
4.7
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG0000.9± 11.9
OG001-1.3± 11.6
OG0021.0± 13.1
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.133
Difference in M--estimates
1.7
2-Sided
95
-0.5
4.0
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in HDL-C (Phase II)
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.9± 14.1
OG0011.0± 16.0
OG002-0.8± 13.7
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.520
Difference in M-estimates
-1.0
2-Sided
95
-4.2
2.1
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001479
OG002938
Title
Denominators
Categories
Title
Measurements
OG000-12.1± 20.7
OG001-6.1± 20.7
OG002-7.6± 20.1
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.003
Difference in M-estimates
-5.3
2-Sided
95
-8.8
-1.8
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Apo B (Phase II)
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.0± 26.5
OG001-6.3± 19.6
OG002-14.0± 25.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.079
Difference in M-estimates
-4.3
2-Sided
95
-9.2
0.5
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001479
OG002938
Title
Denominators
Categories
Title
Measurements
OG000-0.6± 13.1
OG001-1.9± 12.5
OG0021.4± 13.0
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.156
Difference in M-estimates
1.6
2-Sided
95
-0.6
3.8
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Apo A-I (Phase II)
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.6± 11.9
OG0011.4± 14.1
OG002-0.6± 14.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.739
Difference in M-estimates
0.5
2-Sided
95
-2.5
3.6
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Non-HDL-C (Phase I)
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-18.0± 22.3
OG001-7.9± 17.6
OG002-11.1± 19.8
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-10.1
2-Sided
95
-13.6
-6.6
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Non-HDL-C (Phase II)
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-17.5± 26.1
OG001-5.5± 16.6
OG002-18.1± 29.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-9.3
2-Sided
95
-14.0
-4.5
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-14.3± 17.9
OG001-4.5± 16.8
OG002-9.0± 19.1
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-8.1
2-Sided
95
-11.2
-4.9
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-13.5± 21.7
OG001-6.5± 13.9
OG002-11.7± 23.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-6.9
2-Sided
95
-11.0
-2.8
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Phase 1: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-23.9± 23.6
OG001-7.1± 23.2
OG002-14.7± 26.9
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-13.7
2-Sided
95
-18.1
-9.3
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-20.6± 31.4
OG001-8.2± 20.6
OG002-18.2± 31.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-10.4
2-Sided
95
-15.8
-4.9
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Phase 1: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001479
OG002938
Title
Denominators
Categories
Title
Measurements
OG000-13.0± 22.3
OG001-4.8± 18.9
OG002-8.8± 23.0
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-6.3
2-Sided
95
-10.0
-2.5
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-11.2± 26.2
OG001-6.4± 19.4
OG002-11.2± 27.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.024
Difference in M-estimates
-5.8
2-Sided
95
-10.8
-0.8
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Phase 1: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000120
OG001480
OG002939
Title
Denominators
Categories
Title
Measurements
OG000-18.9± 23.9
OG001-6.3± 22.8
OG002-12.2± 25.9
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
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-10.6
2-Sided
95
-14.9
-6.4
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II
Posted
Median
Standard Deviation
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000124
OG001124
OG002231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-18.2± 29.5
OG001-8.8± 18.8
OG002-16.3± 32.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-9.3
2-Sided
95
-14.8
-3.9
Superiority or Other (legacy)
OG002
OG003
Secondary
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.
Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
OG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
OG002
Phase I: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks;
Units
Counts
Participants
OG000117
OG001458
OG002899
Title
Denominators
Categories
Title
Measurements
OG000-10.5(-23.0 to 4.0)
OG001-6.6(-13.6 to 1.0)
OG002-9.0(-14.0 to -3.6)
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
OG001
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.613
Difference in Least-squares Means
-3.9
2-Sided
95
-18.9
11.1
Superiority or Other (legacy)
OG000
OG002
Secondary
Percent Change From Baseline in Hs-CRP (Phase II)
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
ID
Title
Description
OG000
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG001
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
OG002
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
OG003
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
OG004
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
Units
Counts
Participants
OG000119
OG001121
OG002226
OG003
Title
Denominators
Categories
Title
Measurements
OG000-19.5(-31.5 to -5.3)
OG001-6.4(-20.2 to 9.8)
OG002-10.9(-20.9 to 0.3)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.187
Difference in Least-squares Means
-13.1
2-Sided
95
-32.6
6.4
Superiority or Other (legacy)
OG002
OG003
0
120
0
120
EG001
Phase I: Atorvastatin 20 mg
Atorvastatin 20 mg tablet once daily for 6 weeks
3
480
0
480
EG002
Phase I: Rosuvastatin 10 mg
Rosuvastatin 10 mg tablet once daily for 6 weeks
10
939
0
939
EG003
Phase II: EZ 10mg+Atorva 10mg
Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
0
28
0
28
EG004
Phase II: EZ 10mg + Atorva 20mg [A]
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
2
124
0
124
EG005
Phase II: Atorva 40mg
Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
2
124
0
124
EG006
Phase II: EZ 10mg + Atorva 20mg [R]
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
5
231
0
231
EG007
Phase II: Rosuvastatin 20mg
Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
1
205
0
205
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Coronary artery disease
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0061 events1 affected231 at risk
EG0070 events0 affected205 at risk
Myocardial infarction
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0051 events1 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Mental status changes
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0021 events1 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Angina pectoris
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0061 events1 affected231 at risk
EG0070 events0 affected205 at risk
Angina unstable
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0051 events1 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Vitreous haemorrhage
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0041 events1 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Chest pain
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0041 events1 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0070 events0 affected205 at risk
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0061 events1 affected231 at risk
EG0070 events0 affected205 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0061 events1 affected231 at risk
EG0070 events0 affected205 at risk
Cerebral infarction
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected231 at risk
EG0071 events1 affected205 at risk
Calculus urinary
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected480 at risk
EG0020 events0 affected939 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected124 at risk
EG0050 events0 affected124 at risk
EG0061 events1 affected231 at risk
EG0070 events0 affected205 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
D009750
Nutritional and Metabolic Diseases
D011758
Pyrroles
D001393
Azoles
D006538
Heptanoic Acids
D005227
Fatty Acids
D008055
Lipids
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
2 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
4 subjects
FG0052 subjects
FG0065 subjects
FG0074 subjects
6
39
165
531
297
508
205
OG00428
-8.4
± 20.8
OG0042.4± 27.4
OG002
OG003
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.
Difference in M-estimates
-9.5
2-Sided
95
-13.6
-5.5
Superiority or Other (legacy)
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
0.007
Odds Ratio (OR)
1.77
2-Sided
95
1.17
2.67
Superiority or Other (legacy)
201
OG00428
35.8
± 3.38
OG004NAStudy plan did not include the collection of data for this arm for this Phase II endpoint; data not obtained or recorded
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
2.38
2-Sided
95
1.56
3.63
Superiority or Other (legacy)
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
3.90
2-Sided
95
2.23
6.82
Superiority or Other (legacy)
201
OG00428
3.0
± 1.20
OG004NAStudy plan did not include the collection of data for this arm for this Phase II endpoint; data not obtained or recorded
Logistic Regression Model
Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)
<0.001
Odds Ratio (OR)
7.08
2-Sided
95
2.85
17.56
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-5.8
2-Sided
95
-8.3
-3.3
Superiority or Other (legacy)
205
OG00428
-5.0
± 14.0
OG0042.2± 15.4
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-7.4
2-Sided
95
-10.2
-4.5
Superiority or Other (legacy)
Constrained Longitudinal Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.081
Difference in Least-squares means
-4.9
2-Sided
95
-10.3
0.5
Superiority or Other (legacy)
201
OG00428
-3.2
(-7.3 to 1.2)
OG004NA(NA to NA)Study plan did not include the calculation of these values
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.011
Difference in Least-squarres Means
-7.1
2-Sided
95
-12.6
-1.6
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.610
Difference in M-estimates
-0.6
2-Sided
95
-2.7
1.6
Superiority or Other (legacy)
205
OG00428
0.0
± 15.2
OG0040.0± 11.7
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.567
Difference in M-estimates
-0.7
2-Sided
95
-3.1
1.7
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.011
Difference in M-estimates
-4.3
2-Sided
95
-7.7
-1.0
Superiority or Other (legacy)
205
OG00427
-4.9
± 21.8
OG004-4.0± 16.8
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-7.7
2-Sided
95
-11.4
-4.1
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.425
Difference in M-estimates
-0.9
2-Sided
95
-2.9
1.2
Superiority or Other (legacy)
205
OG00427
0.0
± 16.0
OG004-0.7± 14.3
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.410
Difference in M-estimates
-1.0
2-Sided
95
-3.3
1.3
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-7.6
2-Sided
95
-10.9
-4.3
Superiority or Other (legacy)
205
OG00428
-6.3
± 18.5
OG004-0.5± 17.7
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.001
Difference in M-estimates
-9.8
2-Sided
95
-13.5
-6.2
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.001
Difference in M-estimates
-4.8
2-Sided
95
-7.8
-1.9
Superiority or Other (legacy)
205
OG00428
-4.0
± 17.8
OG004-1.0± 9.6
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-6.4
2-Sided
95
-9.4
-3.3
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-7.8
2-Sided
95
-11.9
-3.6
Superiority or Other (legacy)
205
OG00428
-7.5
± 21.5
OG004-4.5± 22.9
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-8.3
2-Sided
95
-12.5
-4.2
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.052
Difference in M-estimates
-3.5
2-Sided
95
-7.1
0.0
Superiority or Other (legacy)
205
OG00427
-5.4
± 21.5
OG004-6.7± 11.3
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.002
Difference in M-estimates
-6.1
2-Sided
95
-9.9
-2.3
Superiority or Other (legacy)
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
0.002
Difference in M-estimates
-6.2
2-Sided
95
-10.2
-2.2
Superiority or Other (legacy)
205
OG00428
-5.9
± 23.4
OG004-1.9± 12.9
Multiple Imputation Robust Regression
M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values
<0.001
Difference in M-estimates
-8.4
2-Sided
95
-12.6
-4.2
Superiority or Other (legacy)
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means
0.831
Difference in Least-squares Means
-1.5
2-Sided
95
-15.7
12.6
Superiority or Other (legacy)
200
OG00427
0.7
(-11.2 to 14.2)
OG004NA(NA to NA)Study plan did not include the calculation of these values
Constrained Longitudinal Data Analysis
Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means