To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

Study Overview
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Brief Summary
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To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: atorvastatin
* Drug: atorvastatin
* Drug: ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe or atorvastatin

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 80 mg | Drug: atorvastatin<br>* Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks<br>|
| Experimental: 2<br>Atorvastatin 40 mg + ezetimibe 10 mg | Drug: atorvastatin<br>* Atorvastatin 40 mg by mouth, once a day for 6 weeks<br>Drug: ezetimibe<br>* Ezetimibe 10 mg tablets 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 to Week 6 in Low-Density Lipoprotein (LDL)-C | Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) | Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 weeks | 
| Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) | Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Total-Cholesterol | Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Triglycerides (TG) | Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) | Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) | Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio | Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio | Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio | Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio | Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100% | Baseline and 6 Weeks | 
| Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) | Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100% | Baseline and 6 Weeks | 
| Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 |  | 6 Weeks |