Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels

This study has been completed.

First Received: August 25, 2004 Last Updated: November 21, 2006 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090298

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 III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

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

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

Show 220 Study Locations

Sponsors and Collaborators

Merck

More Information

Publications:

Catapano AL, Davidson MH, Ballantyne CM, Brady WE, Gazzara RA, Tomassini JE, Tershakovec AM. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006 Oct;22(10):2041-53.

Study ID Numbers:	2004_001
Study First Received:	August 25, 2004
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00090298 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009