Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090168

Purpose

A 6-week treatment study to compare the reduction in cholesterol of two drugs MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.

Condition	Intervention	Phase
Hypercholesterolemia Atherosclerotic Disease Coronary Disease	Drug: MK0653A , ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Duration of Treatment: 6 weeks	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Vascular Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Simvastatin Ezetimibe Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Study to Assess the Cholesterol Lowering Level of Switching to an Investigational Drug Compared to Doubling the Dose of an Investigational Drug in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease

Further study details as provided by Merck:

Primary Outcome Measures:

LDL-C lowering

Secondary Outcome Measures:

Total cholesterol (TC) lowering

Estimated Enrollment:	360
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women greater than or equal to 18 years of age with elevated cholesterol levels and coronary heart disease (CHD), or atherosclerotic vascular disease may be eligible to participate in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090168

Locations

United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Barrios V, Amabile N, Paganelli F, Chen JW, Allen C, Johnson-Levonas AO, Massaad R, Vandormael K. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract. 2005 Dec;59(12):1377-86.

Study ID Numbers:	2004_002
Study First Received:	August 25, 2004
Last Updated:	July 6, 2006
ClinicalTrials.gov Identifier:	NCT00090168
Health Authority:	Estonia: The State Agency of Medicine

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Simvastatin
Myocardial Ischemia
Vascular Diseases
Ezetimibe
Ischemia

Arteriosclerosis
Coronary Disease
Metabolic disorder
Hypercholesterolemia
Atorvastatin
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009