Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10mg or 20mg) in Patients With Coronary Artery Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00442897

Purpose

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

Condition	Intervention	Phase
Hypercholesterolemia	Drug: simvastatin (+) ezetimibe Drug: Comparator: atorvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease

Drug Information available for: Atorvastatin Atorvastatin calcium Simvastatin Ezetimibe Vytorin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease

Further study details as provided by Merck:

Primary Outcome Measures:

Reaching the ldl-c goal (=< ldl-c 100mg/dl) after 6 weeks of treatment according to NCEP, ATP III guidelines [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reaching the ldl-c goal after 12 weeks of the treatment according to NCEP, ATP III guidelines [ Time Frame: after 12 weeks of the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	258
Study Start Date:	March 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: simvastatin (+) ezetimibe simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)
2: Active Comparator	Drug: Comparator: atorvastatin atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are naïve to lowering lipid agent
Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion Criteria:

Impaired kidney function
Increased liver enzyme levels
Pregnant women
Hypersensitivity to ezetimibe and other statin agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442897

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_006, MK0653A-126
Study First Received:	February 28, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00442897
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Merck:

Hypercholesterolaemia

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 16, 2009