Ezetimibe/Simvastatin in Patients With Metabolic Syndrome... | NCT00409773 | Trialant
NCT00409773
Sponsor
Organon and Co
Status
Completed
Last Update Posted
May 16, 2024Actual
Enrollment
1,143Actual
Phase
Phase 3
Conditions
Hypercholesterolemia
Metabolic Syndrome
Interventions
ezetimibe (+) simvastatin
Comparator: atorvastatin calcium
Comparator: Placebo (unspecified)
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
NCT00409773
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0653A-107
Secondary IDs
ID
Type
Description
Link
2006_527
Brief Title
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Official Title
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
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
Jan 2007
Primary Completion Date
Jul 2008Actual
Completion Date
Jul 2008Actual
First Submitted Date
Dec 8, 2006
First Submission Date that Met QC Criteria
Dec 8, 2006
First Posted Date
Dec 11, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2009
Results First Submitted that Met QC Criteria
Jun 17, 2009
Results First Posted Date
Aug 4, 2009Estimated
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
May 8, 2024
Last Update Posted Date
May 16, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Organon and CoINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
Detailed Description
Not provided
Conditions Module
Conditions
Hypercholesterolemia
Metabolic Syndrome
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Other
Arm 1: drug + comparator + Placebo
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
2
Other
Arm 2: drug + comparator + Placebo
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
3
Other
Arm 3: drug + comparator + Placebo
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
4
Other
Arm 4: drug + comparator + Placebo
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
5
Other
Arm 5: drug + comparator + Placebo
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ezetimibe (+) simvastatin
Drug
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
1
2
3
4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Baseline and 6 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Baseline and 6 Weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category
Exclusion Criteria:
A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
Patient is likely to be greater than 20% noncompliant in taking study medications
Patients with chronic medical conditions
Patients with unstable doses of medications
Pregnant or lactating women, women intending to become pregnant
Patient is currently receiving prescription therapy with statins or other lipid-altering medications
Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
Patients were randomized to 1 of 5 treatment groups: ezetimibe/simvastatin combination tablet or atorvastatin alone for 6 weeks stratified according to their baseline risk category stratum (high risk patients with atherosclerotic vascular disease or high risk patients without atherosclerotic vascular disease and moderately high risk patients).
Recruitment Details
Phase III
First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008
Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
FG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
FG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
FG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
FG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000229 subjects
FG001229 subjects
FG002229 subjects
FG003228 subjects
FG004228 subjects
COMPLETED
FG000220 subjects
FG001222 subjects
FG002220 subjects
FG003216 subjects
FG004
NOT COMPLETED
FG0009 subjects
FG0017 subjects
FG0029 subjects
FG00312 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
BG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 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, Continuous
Mean
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 (LDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
Adverse Events Module
Frequency Threshold
1
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Gastrointestinal Disorders
Gastrointestinal disorders
Non-systematic Assessment
More Info Module
Limitations and Caveats
15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
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
Australia
Colombia
Ecuador
Germany
Greece
Hungary
Italy
Malaysia
Netherlands
Peru
South Korea
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006937
Hypercholesterolemia
D024821
Metabolic Syndrome
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
D000069499
Ezetimibe, Simvastatin Drug Combination
D000069059
Atorvastatin
Ancestor Terms
ID
Term
D019821
Simvastatin
D008148
Lovastatin
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
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
5
MK0653A
Vytorin®
Comparator: atorvastatin calcium
Drug
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
1
2
3
4
5
Lipitor ®
Comparator: Placebo (unspecified)
Drug
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
1
2
3
4
5
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Baseline and 6 weeks
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Baseline and 6 Weeks
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Baseline and 6 Weeks
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Baseline and 6 Weeks
Derived
Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
218 subjects
10 subjects
2 subjects
FG0046 subjects
Lost to Follow-up
FG0006 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0041 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0041 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
Lack of Eligibility
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
BG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
BG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
BG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
BG005
Total
Total of all reporting groups
229
BG001229
BG002229
BG003228
BG004228
BG0051143
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00059.7(31 to 79)
BG00159.7(32 to 78)
BG00258.2(33 to 78)
BG00359.5(28 to 80)
BG00458.4(28 to 79)
BG00559.1(28 to 80)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00097
BG00187
BG002106
BG003104
BG004104
BG005498
Male
BG000132
BG001142
BG002123
BG003124
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG00017
BG00115
BG00215
BG00318
BG00421
BG00586
Black
Title
Measurements
BG00013
BG00118
BG00218
BG003
Other
Title
Measurements
BG00027
BG00127
BG00219
BG003
White
Title
Measurements
BG000172
BG001169
BG002177
BG003
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002215
OG003217
OG004217
Title
Denominators
Categories
Title
Measurements
OG000-36.5(-38.9 to -34.0)
OG001-49.6(-52.0 to -47.2)
OG002-39.4(-41.8 to -36.9)
OG003-53.9(-56.4 to -51.5)
OG004-46.0(-48.4 to -43.6)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.
Mean Difference (Final Values)
-13.1
Standard Error of the Mean
1.7
95
-16.5
-9.8
Superiority or Other (legacy)
OG001
OG002
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.
Mean Difference (Final Values)
-10.2
Standard Error of the Mean
1.7
95
-13.6
-6.9
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.
Mean Difference (Final Values)
-8.0
Standard Error of the Mean
1.7
95
-11.3
-4.6
Superiority or Other (legacy)
Secondary
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001220
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-26.5(-28.2 to -24.7)
OG001-33.7(-35.4 to -31.9)
OG002-28.3(-30.1 to -26.6)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-7.2
Standard Error of the Mean
1.2
95
-9.6
-4.8
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Median
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001220
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.7(-25.0 to -17.9)
OG001-23.3(-26.9 to -18.2)
OG002-27.5(-30.8 to -22.4)
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
Non-parametric ANOVA
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
0.690
Mean Difference (Final Values)
-0.9
95
-5.4
3.3
Superiority or Other (legacy)
OG001
OG002
Non-parametric ANOVA
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.4(1.5 to 5.3)
OG0016.8(4.9 to 8.7)
OG0025.6(3.7 to 7.5)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
0.013
Mean Difference (Final Values)
3.4
Standard Error of the Mean
1.3
95
0.7
6.0
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-33.5(-35.6 to -31.3)
OG001-43.8(-45.9 to -41.7)
OG002-36.5(-38.6 to -34.4)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-10.3
Standard Error of the Mean
1.5
95
-13.3
-7.3
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001217
OG002209
OG003
Title
Denominators
Categories
Title
Measurements
OG000-17.7(-21.4 to -14.0)
OG001-18.3(-22.0 to -14.7)
OG002-21.6(-25.3 to -17.8)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
0.809
Mean Difference (Final Values)
-0.6
Standard Error of the Mean
2.6
95
-5.7
4.5
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000211
OG001218
OG002213
OG003
Title
Denominators
Categories
Title
Measurements
OG000-27.9(-29.9 to -25.9)
OG001-37.2(-39.2 to -35.3)
OG002-31.9(-33.9 to -29.9)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-9.4
Standard Error of the Mean
1.4
95
-12.1
-6.6
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000211
OG001219
OG002213
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.8(-1.0 to 2.5)
OG0013.2(1.5 to 4.9)
OG0021.0(-0.7 to 2.7)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
0.042
Mean Difference (Final Values)
2.4
Standard Error of the Mean
1.2
95
0.1
4.8
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-28.1(-30.1 to -26.0)
OG001-36.9(-38.9 to -34.8)
OG002-31.5(-33.6 to -29.5)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-8.8
Standard Error of the Mean
1.4
95
-11.6
-6.0
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002215
OG003
Title
Denominators
Categories
Title
Measurements
OG000-37.8(-40.3 to -35.2)
OG001-51.8(-54.3 to -49.3)
OG002-42.1(-44.7 to -39.6)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-14.0
Standard Error of the Mean
1.8
95
-17.6
-10.5
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000211
OG001218
OG002213
OG003
Title
Denominators
Categories
Title
Measurements
OG000-27.4(-29.6 to -25.2)
OG001-38.4(-40.6 to -36.2)
OG002-32.0(-34.2 to -29.8)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-11.0
Standard Error of the Mean
1.5
95
-14.0
-8.0
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000215
OG001219
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-34.7(-37.2 to -32.2)
OG001-46.2(-48.6 to -43.7)
OG002-39.2(-41.7 to -36.7)
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
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-11.5
Standard Error of the Mean
1.8
95
-15.0
-8.1
Superiority or Other (legacy)
OG001
OG002
ANOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG00064
OG00171
OG00259
OG003
Title
Denominators
Categories
Title
Measurements
OG000-37.1(-41.4 to -32.7)
OG001-48.7(-52.8 to -44.6)
OG002-36.9(-41.5 to -32.4)
OG003
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000151
OG001148
OG002156
OG003
Title
Denominators
Categories
Title
Measurements
OG000-36.3(-39.1 to -33.5)
OG001-50.1(-52.9 to -47.2)
OG002-40.3(-43.1 to -37.6)
OG003
Secondary
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Posted
Median
95% Confidence Interval
Percent Change
Baseline and 6 Weeks
ID
Title
Description
OG000
Atorva 10 mg
Atorvastatin 10 mg once daily for 6 weeks
OG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
OG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
OG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
OG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
Units
Counts
Participants
OG000216
OG001218
OG002210
OG003
Title
Denominators
Categories
Title
Measurements
OG000-16.8(-21.7 to -10.6)
OG001-17.2(-24.1 to -12.5)
OG002-22.4(-26.1 to -14.6)
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
Non-parametric ANOVA
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
0.420
Median Difference (Final Values)
-2.9
95
-11.0
5.0
Superiority or Other (legacy)
OG001
OG002
Non-parametric ANOVA
4
21
EG001
EZ/Simva 10 mg/20 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
0
14
EG002
Atorva 20mg
Atorvastatin 20 mg once daily for 6 weeks
1
22
EG003
EZ/Simva 10 mg/40 mg
Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1
13
EG004
Atorva 40 mg
Atorvastatin 40 mg once daily for 6 weeks
4
13
EG0001 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Atrial Fibrillation
Cardiac disorders
Non-systematic Assessment
EG0001 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Atrioventricular Block Second Degree
Cardiac disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0031 affected224 at risk
EG0040 affected224 at risk
Sick Sinus Syndrome
Cardiac disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0021 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Tachyarrhythmia
Cardiac disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0041 affected224 at risk
Cholestasis
Hepatobiliary disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0041 affected224 at risk
Urinary Tract Infection
Infections and infestations
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0021 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0041 affected224 at risk
Cerebrovascular Accident
Nervous system disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0041 affected224 at risk
Headache
Nervous system disorders
Non-systematic Assessment
EG0001 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Ischaemic Cerebral Infarction
Nervous system disorders
Non-systematic Assessment
EG0001 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
EG0007 affected228 at risk
EG0016 affected226 at risk
EG0027 affected226 at risk
EG0034 affected224 at risk
EG0042 affected224 at risk
Abdominal Tenderness
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected228 at risk
EG0012 affected226 at risk
EG0023 affected226 at risk
EG0031 affected224 at risk
EG0040 affected224 at risk
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG0005 affected228 at risk
EG0011 affected226 at risk
EG0023 affected226 at risk
EG0031 affected224 at risk
EG0041 affected224 at risk
Nausea
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected228 at risk
EG0013 affected226 at risk
EG0021 affected226 at risk
EG0032 affected224 at risk
EG0041 affected224 at risk
Any General Disorders And Administration Site Conditions
General disorders
Non-systematic Assessment
EG0002 affected228 at risk
EG0012 affected226 at risk
EG0022 affected226 at risk
EG0031 affected224 at risk
EG0040 affected224 at risk
Fatigue
General disorders
Non-systematic Assessment
EG0002 affected228 at risk
EG0012 affected226 at risk
EG0022 affected226 at risk
EG0031 affected224 at risk
EG0040 affected224 at risk
Any Infections and Infestations
Infections and infestations
Non-systematic Assessment
EG0001 affected228 at risk
EG0011 affected226 at risk
EG0022 affected226 at risk
EG0032 affected224 at risk
EG0041 affected224 at risk
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected228 at risk
EG0011 affected226 at risk
EG0022 affected226 at risk
EG0032 affected224 at risk
EG0041 affected224 at risk
Any Musculoskeletal And Connective Tissue Disorders
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0008 affected228 at risk
EG0017 affected226 at risk
EG0029 affected226 at risk
EG0035 affected224 at risk
EG0047 affected224 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0003 affected228 at risk
EG0011 affected226 at risk
EG0021 affected226 at risk
EG0032 affected224 at risk
EG0041 affected224 at risk
Back Pain
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0012 affected226 at risk
EG0020 affected226 at risk
EG0033 affected224 at risk
EG0042 affected224 at risk
Muscle Spasms
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0002 affected228 at risk
EG0012 affected226 at risk
EG0023 affected226 at risk
EG0030 affected224 at risk
EG0041 affected224 at risk
Myalgia
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0003 affected228 at risk
EG0012 affected226 at risk
EG0023 affected226 at risk
EG0030 affected224 at risk
EG0043 affected224 at risk
Pain In Extremity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0003 affected228 at risk
EG0011 affected226 at risk
EG0022 affected226 at risk
EG0031 affected224 at risk
EG0041 affected224 at risk
Any Nervous System Disorders
Nervous system disorders
Non-systematic Assessment
EG0004 affected228 at risk
EG0012 affected226 at risk
EG0024 affected226 at risk
EG0033 affected224 at risk
EG0042 affected224 at risk
Dizziness
Nervous system disorders
Non-systematic Assessment
EG0000 affected228 at risk
EG0012 affected226 at risk
EG0020 affected226 at risk
EG0033 affected224 at risk
EG0040 affected224 at risk
Headache
Nervous system disorders
Non-systematic Assessment
EG0004 affected228 at risk
EG0010 affected226 at risk
EG0024 affected226 at risk
EG0030 affected224 at risk
EG0042 affected224 at risk
Any Vascular Disorders
Vascular disorders
Non-systematic Assessment
EG0002 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0042 affected224 at risk
Hypertension
Vascular disorders
Non-systematic Assessment
EG0002 affected228 at risk
EG0010 affected226 at risk
EG0020 affected226 at risk
EG0030 affected224 at risk
EG0040 affected224 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
D009750
Nutritional and Metabolic Diseases
D007333
Insulin Resistance
D006946
Hyperinsulinism
D044882
Glucose Metabolism Disorders
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D000069438
Ezetimibe
D001384
Azetidines
D001385
Azetines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011083
Polycyclic Compounds
D004338
Drug Combinations
D004364
Pharmaceutical Preparations
D011758
Pyrroles
D001393
Azoles
D006538
Heptanoic Acids
D005227
Fatty Acids
D008055
Lipids
124
BG005645
12
BG00414
BG00575
27
BG00426
BG005126
171
BG004167
BG005856
217
OG004218
-37.3
(-39.0 to -35.5)
OG004-32.8(-34.6 to -31.1)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.4
Standard Error of the Mean
1.2
95
-7.8
-2.9
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-4.4
Standard Error of the Mean
1.2
95
-6.8
-2.0
Superiority or Other (legacy)
217
OG004218
-29.5
(-32.5 to -25.0)
OG004-30.0(-34.2 to -26.5)
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
0.200
Median Difference (Final Values)
2.8
95
-1.6
7.1
Superiority or Other (legacy)
OG003
OG004
Non-parametric ANOVA
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
0.480
Median Difference (Final Values)
-0.4
95
-4.7
3.9
Superiority or Other (legacy)
217
OG004217
8.8
(6.9 to 10.7)
OG0044.9(3.0 to 6.8)
ANOVA with terms for treatment and baseline risk stratum
0.378
Mean Difference (Final Values)
1.2
Standard Error of the Mean
1.3
95
-1.5
3.8
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
0.003
Mean Difference (Final Values)
4.0
Standard Error of the Mean
1.3
95
1.3
6.6
Superiority or Other (legacy)
217
OG004217
-48.3
(-50.5 to -46.2)
OG004-41.4(-43.6 to -39.3)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-7.3
Standard Error of the Mean
1.5
95
-10.2
-4.3
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-6.9
Standard Error of the Mean
1.5
95
-9.9
-3.9
Superiority or Other (legacy)
214
OG004216
-23.4
(-27.1 to -19.7)
OG004-22.7(-26.4 to -19.0)
ANOVA with terms for treatment and baseline risk stratum
0.217
Mean Difference (Final Values)
3.2
Standard Error of the Mean
2.6
95
-1.9
8.4
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
0.796
Mean Difference (Final Values)
-0.7
Standard Error of the Mean
2.6
95
-5.8
4.4
Superiority or Other (legacy)
214
OG004216
-41.1
(-43.1 to -39.1)
OG004-35.8(-37.8 to -33.8)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.3
Standard Error of the Mean
1.4
95
-8.1
-2.6
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.3
Standard Error of the Mean
1.4
95
-8.0
-2.5
Superiority or Other (legacy)
214
OG004216
3.0
(1.3 to 4.7)
OG0041.4(-0.3 to 3.1)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
2.2
Standard Error of the Mean
1.2
95
-0.2
4.5
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
1.6
Standard Error of the Mean
1.2
95
-7.0
4.0
Superiority or Other (legacy)
217
OG004217
-41.2
(-43.2 to -39.1)
OG004-35.3(-37.3 to -33.2)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.3
Standard Error of the Mean
1.4
95
-8.2
-2.5
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.9
Standard Error of the Mean
1.4
95
-8.7
-3.1
Superiority or Other (legacy)
217
OG004217
-56.6
(-59.2 to -54.1)
OG004-48.2(-50.7 to -45.6)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-9.7
Standard Error of the Mean
1.8
95
-13.2
-6.1
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-8.5
Standard Error of the Mean
1.8
95
-12.0
-4.9
Superiority or Other (legacy)
214
OG004216
-41.9
(-44.1 to -39.7)
OG004-36.2(-38.4 to -34.0)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-6.4
Standard Error of the Mean
1.5
95
-9.4
-3.3
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-5.7
Standard Error of the Mean
1.5
95
-8.7
-2.7
Superiority or Other (legacy)
217
OG004217
-51.2
(-53.7 to -48.7)
OG004-43.5(-46.0 to -41.0)
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-7.0
Standard Error of the Mean
1.8
95
-10.4
-3.6
Superiority or Other (legacy)
OG003
OG004
ANOVA
ANOVA with terms for treatment and baseline risk stratum
<0.001
Mean Difference (Final Values)
-7.7
Standard Error of the Mean
1.8
95
-11.2
-4.3
Superiority or Other (legacy)
61
OG00463
-56.1
(-60.6 to -51.7)
OG004-45.8(-50.2 to -41.5)
156
OG004154
-53.2
(-55.9 to -50.4)
OG004-46.1(-48.9 to -43.3)
216
OG004215
-27.6
(-33.3 to -21.4)
OG004-30.0(-33.3 to -25.0)
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum
0.555
Median Difference (Final Values)
-0.9
95
-9.5
7.2
Superiority or Other (legacy)
OG003
OG004
Non-parametric ANOVA
ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum