Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Metabolic Syndrome

Intervention / Treatment
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* Drug: ezetimibe (+) simvastatin
* Drug: Comparator: atorvastatin calcium
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Arm 1: drug + comparator + Placebo | Drug: ezetimibe (+) simvastatin<br>* Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.<br>* Other names: Vytorin®;Drug: Comparator: atorvastatin calcium<br>* 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.<br>* Other names: Lipitor ®;Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|
| Other: 2<br>Arm 2: drug + comparator + Placebo | Drug: ezetimibe (+) simvastatin<br>* Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.<br>* Other names: Vytorin®;Drug: Comparator: atorvastatin calcium<br>* 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.<br>* Other names: Lipitor ®;Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|
| Other: 3<br>Arm 3: drug + comparator + Placebo | Drug: ezetimibe (+) simvastatin<br>* Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.<br>* Other names: Vytorin®;Drug: Comparator: atorvastatin calcium<br>* 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.<br>* Other names: Lipitor ®;Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|
| Other: 4<br>Arm 4: drug + comparator + Placebo | Drug: ezetimibe (+) simvastatin<br>* Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.<br>* Other names: Vytorin®;Drug: Comparator: atorvastatin calcium<br>* 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.<br>* Other names: Lipitor ®;Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|
| Other: 5<br>Arm 5: drug + comparator + Placebo | Drug: ezetimibe (+) simvastatin<br>* Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.<br>* Other names: Vytorin®;Drug: Comparator: atorvastatin calcium<br>* 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.<br>* Other names: Lipitor ®;Drug: Comparator: Placebo (unspecified)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 |  | Baseline and 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |