A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

Study Overview
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Brief Summary
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To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Detailed Description
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Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol

Conditions
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Cholesterol

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males between the ages of 18-55 with LDL More than 130, but less than 180 Exclusion Criteria: Individuals with drug or substance abuse Individuals with poor mental function Individuals having more than 14 alcoholic drinks a week Individuals that have been treated with any other investigational drug in the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ezetimibe 10 mg tablet plus simvastatin 20 mg tablet | Drug: ezetimibe<br>* ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.<br>* Other names: MK0653;Drug: simvastatin<br>* simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.<br>* Other names: MK0733;|
| Active Comparator: 2<br>ezetimibe 10 mg tablet | Drug: ezetimibe<br>* ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.<br>* Other names: MK0653;Drug: Comparator: Placebo (unspecified)<br>* matching placebo tablet. Duration of Treatment 31 Weeks.<br>|
| Active Comparator: 3<br>simvastatin 20 mg tablet | Drug: Comparator: Placebo (unspecified)<br>* matching placebo tablet. Duration of Treatment 31 Weeks.<br>Drug: simvastatin<br>* simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.<br>* Other names: MK0733;|
| Placebo Comparator: 4<br>matching placebo | Drug: Comparator: Placebo (unspecified)<br>* matching placebo tablet. Duration of Treatment 31 Weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. |  | Based on 7 week treatment periods. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. |  | Based on 7 week treatment periods. |