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

February 7, 2022 updated by: Organon and Co

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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: simvastatin
simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
Other Names:
  • MK0733
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.
PLACEBO_COMPARATOR: 4
matching placebo
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

Schering-Plough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

April 1, 2004

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (ESTIMATE)

April 3, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-050
  • MK0653-050
  • 2007_559

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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