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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00652301

Collaborator

Schering-Plough (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cholesterol	Drug: ezetimibe Drug: Comparator: Placebo (unspecified) Drug: simvastatin	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ezetimibe 10 mg tablet plus simvastatin 20 mg tablet	Drug: ezetimibe ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. Other Names: MK0653 Drug: simvastatin simvastatin 20 mg tablet. Duration of Treatment 31 Weeks. Other Names: MK0733
Active Comparator: 2 ezetimibe 10 mg tablet	Drug: ezetimibe ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. Other Names: MK0653 Drug: Comparator: Placebo (unspecified) matching placebo tablet. Duration of Treatment 31 Weeks.
Active Comparator: 3 simvastatin 20 mg tablet	Drug: Comparator: Placebo (unspecified) matching placebo tablet. Duration of Treatment 31 Weeks. Drug: simvastatin simvastatin 20 mg tablet. Duration of Treatment 31 Weeks. Other Names: MK0733
Placebo Comparator: 4 matching placebo	Drug: Comparator: Placebo (unspecified) matching placebo tablet. Duration of Treatment 31 Weeks.

Outcome Measures

Primary Outcome Measures

reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [Based on 7 week treatment periods.]

Secondary Outcome Measures

To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. [Based on 7 week treatment periods.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co
Schering-Plough

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00652301

Other Study ID Numbers:

0653-050
MK0653-050
2007_559

First Posted:

Apr 3, 2008

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Simvastatin

Ezetimibe

Study Results

No Results Posted as of Feb 18, 2022