To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Official Title
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A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Comparator: atorvastatin
* Drug: Comparator: Placebo
* Drug: Comparator: ezetimibe
* Drug: Comparator: Placebo.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin Patient with diabetes or coronary heart disease

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 |
| --- | --- |
| Active Comparator: 1<br>Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). | Drug: Comparator: atorvastatin<br>* Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks<br>Drug: Comparator: Placebo<br>* Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks<br>|
| Experimental: 2<br>Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). | Drug: Comparator: ezetimibe<br>* Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.<br>Drug: Comparator: Placebo.<br>* Atorvastatin 40mg Pbo tablets po qd (by mouth, once a 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-Cholesterol (LDL-C) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 weeks | 
| Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Total-Cholesterol at Week 6 | ([6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Triglycerides (TG) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 weeks | 
| Percent Change From Baseline in Apolipoprotein B at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | 6 Weeks | 
| Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6 |  | 6 weeks |