Effect of an Investigational Compound on Tolerability of Extended Release Niacin - Full Text View

Purpose

This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.

Condition	Intervention	Phase
Hypercholesteremia Hyperlipidemia	Drug: niacin (+) laropiprant Drug: Comparator : niacin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Niacinamide

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Global Flushing Severity Score (GFSS) during 7 days of treatment [ Time Frame: during 7 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety/Tolerability

Enrollment:	825
Study Start Date:	September 2006
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 10 Weeks

Other Name: MK0524A

Duration of Treatment: 2 Weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is appropriate candidate for niacin therapy
Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
Patient has TG <500 mg/dL (5.65 mmol/L) at V1
A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion Criteria:

Patients with unstable doses of medications
Pregnant or lactating women, or women intending to become pregnant are excluded
Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376584

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00376584 History of Changes
Other Study ID Numbers:	2006_504, MK0524A-023
Study First Received:	September 14, 2006
Last Updated:	March 5, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Primary Hypercholesteremia
Mixed Hyperlipidemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Niacinamide
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

ClinicalTrials.gov processed this record on May 19, 2013