Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090298
First received: August 25, 2004
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.


Condition Intervention Phase
Hypercholesterolemia
Drug: MK0653A, ezetimibe (+) simvastatin
Drug: Comparator: Rosuvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • LDL-C lowering efficacy after 6 weeks.

Secondary Outcome Measures:
  • Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.

Estimated Enrollment: 2725
Study Start Date: May 2004
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090298

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00090298     History of Changes
Other Study ID Numbers: 2004_001, MK0653A-058
Study First Received: August 25, 2004
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014