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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652301

Enrollment

Registered

2008-04-03

Start date

2003-07-31

Completion date

2004-04-30

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol

Brief summary

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

Detailed description

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

Interventions

DRUGezetimibe

ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.

DRUGComparator: Placebo (unspecified)

matching placebo tablet. Duration of Treatment 31 Weeks.

DRUGsimvastatin

simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.	Based on 7 week treatment periods.

Secondary

Measure	Time frame
To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.	Based on 7 week treatment periods.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026