Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 20, 2006
Last updated: December 1, 2014
Last verified: December 2014
This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

Condition Intervention Phase
Drug: niacin (+) laropiprant
Drug: niacin
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 Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Global Flushing Severity Score (GFSS) over 16 weeks

Secondary Outcome Measures:
  • Safety/tolerability

Enrollment: 1300
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: niacin (+) laropiprant
    Duration of Treatment: 18 Weeks
    Other Name: MK0524A
    Drug: niacin
    Duration of Treatment: 18 Weeks

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

Inclusion Criteria:

  • Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion Criteria:

  • Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
  • Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
  • Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00378833

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00378833     History of Changes
Other Study ID Numbers: 0524A-054, 2006_529
Study First Received: September 20, 2006
Last Updated: December 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Primary Hypercholesterolemia or Mixed Hyperlipidemia

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins processed this record on November 30, 2015