Lipid Efficacy Study - Full Text View

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 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, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Niacinamide Simvastatin

U.S. FDA Resources

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

Other Name: MK0524B

Duration of Treatment 12 Weeks

Other Name: MK0524A

Duration of Treatment 12 Weeks

Other Name: MK0733

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

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ballantyne C, Gleim G, Liu N, Sisk CM, Johnson-Levonas AO, Mitchel Y. Effects of coadministered extended-release niacin/laropiprant and simvastatin on lipoprotein subclasses in patients with dyslipidemia. J Clin Lipidol. 2012 May;6(3):235-43. Epub 2011 Dec 3.

Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00269217 History of Changes
Other Study ID Numbers:	2005_098, MK0524B-022
Study First Received:	December 21, 2005
Last Updated:	March 6, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Niacin
Simvastatin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013