Lipid Efficacy Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00269217

Purpose

This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.

Condition	Intervention	Phase
Primary Hypercholesterolemia Mixed Hyperlipidemia	Drug: niacin (+) laropiprant (+) simvastatin Drug: Comparator: niacin (+) laropiprant Drug: Comparator: simvastatin	Phase III

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Laropiprant Simvastatin Niacin Niacin hydrochloride Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Further study details as provided by Merck:

Primary Outcome Measures:

Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measures:

Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.

Enrollment:	1400
Study Start Date:	January 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment 12 Weeks

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.

Exclusion Criteria:

A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Patients with <80% compliance
Patients with certain medical conditions
Patients taking certain concomitant medications and/or with unstable doses of medications
Or those with a history of CHD/CHD equivalent or diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269217

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:	2005_098, MK0524B-022
Study First Received:	December 21, 2005
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00269217
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Simvastatin
Combined hyperlipidemia, familial
Metabolism, Inborn Errors
Nicotinic Acids

Genetic Diseases, Inborn
Hyperlipidemia, Familial Combined
Metabolic disorder
Hypercholesterolemia
Niacin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009