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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653-112 | |||
| 2006_549 |
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A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe and atorvastatin | Drug | ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and Week 6 | |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20185012 | Result | Zieve F, Wenger NK, Ben-Yehuda O, Constance C, Bird S, Lee R, Hanson ME, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe added to atorvastatin versus up titration of atorvastatin to 40 mg in Patients > or = 65 years of age (from the ZETia in the ELDerly [ZETELD] study). Am J Cardiol. 2010 Mar 1;105(5):656-63. doi: 10.1016/j.amjcard.2009.10.029. Epub 2009 Dec 24. | |
| 24411003 |
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Patients were stratified based on baseline LDL-C levels and presence or absence of atherosclerotic vascular
disease to achieve balance across treatment groups.
Phase III
First Patient In: 28-Feb-2007; Last Patient Last Visit: 01-Oct-2008
143 centers worldwide (United States, Canada, Poland, Romania, Ukraine and Russia)
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorva 10 mg + EZ | [Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks |
| FG001 | Atorva 20 mg / Atorva 40 mg | Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorva 10 mg + EZ | [Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks |
| BG001 | Atorva 20 mg / Atorva 40 mg | Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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 Week 6 |
|
Not provided
The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
Not provided
| 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 + EZ | [Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| atorvastatin |
| Drug |
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks |
|
| Placebo (unspecified) | Drug | Placebo (unspecified) daily for 12 weeks |
|
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Week 12 |
| Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | Week 6 |
| Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | Week 12 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseine and Week 12 |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Triglycerides (TG) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Triglycerides (TG) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 | Baseline and Week 12 |
| Derived |
| Constance C, Ben-Yehuda O, Wenger NK, Zieve F, Lin J, Hanson ME, Lowe RS, Tershakovec AM. Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects >/=65 years. Lipids Health Dis. 2014 Jan 13;13:13. doi: 10.1186/1476-511X-13-13. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| BMI [Body Mass Index (<30, ≥30 kg/m2)] | Number | Participants |
|
| Apo lipoprotein A-I (Apo A-I) | Mean | Standard Deviation | mg/dL |
|
| Apo lipoprotein B (Apo B) | Mean | Standard Deviation | mg/dL |
|
| Apo lipoprotein B (Apo B):Apo lipoprotein A-I (Apo A-I) Ratio | Mean | Standard Deviation | Ratio |
|
| High Density Lipoprotein Cholesterol (HDL-C) | Mean | Standard Deviation | mg/dL |
|
| Highly selective C-reactive protein (hs-CRP) | Robust Standard Deviation was calculated for hs-CRP as: interquartile range (IQR)/1.075, where IQR=3rd quartile - 1st quartile. | Mean | Standard Deviation | mg/L |
|
| Low Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
|
| Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio | Mean | Standard Deviation | Ratio |
|
| Non-High Density Lipoprotein Cholesterol (Non-HDL-C) | Mean | Standard Deviation | mg/dL |
|
| Non-High Density Lipoprotein Cholesterol (Non-HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ra | Mean | Standard Deviation | Ratio |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Total Cholesterol (TC):High Density Lipoprotein-C (HDL-C) Ratio | Mean | Standard Deviation | Ratio |
|
| Triglycerides (TG) | Robust Standard Deviation was calculated for Triglycerides as: interquartile range (IQR)/1.075, where IQR=3rd quartile - 1st quartile. | Mean | Standard Deviation | mg/dL |
|
|
|
|
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 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 Week 12 |
|
|
|
|
| Secondary | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 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 | Number | Participants | Week 6 |
|
|
|
|
| Secondary | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | 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 | Number | Participants | Week 12 |
|
|
|
|
| Secondary | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) 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 | Number | Participants | Week 6 |
|
|
|
|
| Secondary | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | 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 | Number | Participants | Week 12 |
|
|
|
|
| Other Pre-specified | 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | 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 | Baseine and Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Cholesterol (TC) 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Triglycerides (TG) 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Triglycerides (TG) at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | 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 Week 12 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) 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 Week 6 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 | 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 Week 12 |
|
|
|
|
| 15 |
| 46 |
| EG001 | Atorva 20 mg / Atorva 40 mg | Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks | 14 | 54 |
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Appendicitis perforated | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Death | General disorders | MedDRA | Non-systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Asparate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
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 |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |