Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 23, 2004
Last updated: October 30, 2015
Last verified: October 2015
The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Condition Intervention Phase
Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks
Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

Secondary Outcome Measures:
  • Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
  • Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

Enrollment: 655
Study Start Date: May 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elevated cholesterol levels

Exclusion Criteria:

  • Liver disease
  • Unstable medical conditions
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092716     History of Changes
Other Study ID Numbers: 0653-025, 2004_047
Study First Received: September 23, 2004
Last Updated: October 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015