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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: February 15, 2017
Last verified: February 2017
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
Hypercholesterolemia Hyperlipidemia Drug: niacin (+) laropiprant Drug: niacin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Study Data/Documents: CSR synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00378833     History of Changes
Other Study ID Numbers: 0524A-054
Study First Received: September 20, 2006
Last Updated: February 15, 2017

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 20, 2017