A Study to Evaluate the Effects of MK0653 on the Postprandial (Following a Meal) Lipoprotein Response in Patients With Primary Hypercholesterolemia (High Cholesterol)

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: January 10, 2005
Last updated: January 25, 2010
Last verified: January 2010

A study to evaluate the cholesterol-lowering effects of MK0653 in patients with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol.

Condition Intervention Phase
Drug: ezetimibe
Drug: Comparator: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Postprandial Lipoprotein Response in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Reduction of plasma cholesterol

Enrollment: 60
Study Start Date: March 2005
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ezetimibe
    Duration of Treatment: 56 days
    Other Name: MK0653
    Drug: Comparator: placebo
    Duration of Treatment: 56 days

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol.

Exclusion Criteria:

  • Individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101439

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00101439     History of Changes
Other Study ID Numbers: 2005_001, MK0653-072
Study First Received: January 10, 2005
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Primary Hypercholesterolemia

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014