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An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 26, 2005
Last updated: July 29, 2015
Last verified: July 2015
This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.

Condition Intervention Phase
Drug: niacin (+) laropiprant
Drug: Comparator: placebo (unspecified)
Phase 2

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 Dose Ranging Study to Evaluate the Tolerability of MK0524 (Niacin (+) Laropiprant) and Its Effects on Niacin-Induced Acute Flushing in Lipid Clinic Patients and/or Normal Healthy Subjects

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Acute cutaneous symptoms induced by niacin for 7 days. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 575
Study Start Date: June 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: niacin (+) laropiprant
    Other Name: MK0524A
    Drug: Comparator: placebo (unspecified)
Detailed Description:
The duration of treatment is 7 days.

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and females (ages 25-75)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00111891

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00111891     History of Changes
Other Study ID Numbers: 0524-032  MK0524A-032  2005_032 
Study First Received: May 26, 2005
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration

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 December 09, 2016