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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092716
First received: September 23, 2004
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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
Hypercholesterolemia
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)
  Eligibility

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

Inclusion Criteria:

  • Elevated cholesterol levels

Exclusion Criteria:

  • Liver disease
  • Unstable medical conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092716     History of Changes
Other Study ID Numbers: 0653-025, 2004_047
Study First Received: September 23, 2004
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2015