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

Organon and Co40 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Cholesterol

Interventions

ezetimibeDRUG

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

Comparator: Placebo (unspecified)DRUG

matching placebo tablet. Duration of Treatment 31 Weeks.

simvastatinDRUG

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.

Time frame: Based on 7 week treatment periods.

Secondary Outcomes

To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.

Time frame: Based on 7 week treatment periods.

Data from ClinicalTrials.gov

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