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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.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00101439
First received: January 10, 2005
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Hypercholesterolemia
 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:

MedlinePlus related topics: Cholesterol
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

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
  Eligibility

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

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
Investigators
Study Director: Medical Monitor Merck
  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:
Primary Hypercholesterolemia

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

ClinicalTrials.gov processed this record on May 21, 2013