Lipid Efficacy/Tolerability Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00269204

Purpose

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

Condition	Intervention	Phase
Primary Hypercholesterolaemia Mixed Hyperlipidaemia	Drug: niacin (+) laropiprant Drug: ER-niacin	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 Niacin Niacin hydrochloride Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Further study details as provided by Merck:

Primary Outcome Measures:

Reductions of LDL-C concentrations at 24 weeks and better tolerability [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Elevations in HDL-C concentrations at 24 weeks [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	1620
Study Start Date:	December 2005
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment - 24 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 with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD), have medical conditions considered to be CHD equivalent), LDL-C below 130 mg/dL for patients with multiple risk factors, LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 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 <20% compliance, patients with chronic medical conditions, patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregnant are excluded. Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269204

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_095
Study First Received:	December 21, 2005
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00269204
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
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
Vasodilator Agents
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Antilipemic Agents
Therapeutic Uses
Physiological Effects of Drugs
Micronutrients
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009