A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Study Overview
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Brief Summary
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This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Official Title
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A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

Conditions
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Hypercholesterolemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is currently taking a statin medication for the treatment of high cholesterol Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl Exclusion Criteria: Women who are pregnant or nursing, or women who intend to become pregnant Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

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 |
| --- | --- |
| Experimental: 1<br>Arm 1: drug | Drug: ezetimibe (+) simvastatin<br>* ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.<br>* Other names: Vytorin®;Drug: Comparator: Placebo (unspecified)<br>* rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.<br>|
| Active Comparator: 2<br>Arm 2: active comparator | Drug: Comparator : rosuvastatin calcium<br>* rosuvastatin 10mg. The treatment duration will be 6 weeks.<br>Drug: Comparator: Placebo (unspecified)<br>* ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment | Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment | The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group. | after 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Cholesterol