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An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00111891
First received: May 26, 2005
Last updated: July 30, 2008
Last verified: July 2008
History of Changes
  Purpose

This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.


Condition Intervention Phase
Dyslipidemia
 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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Intervention Details:
    Drug: niacin (+) laropiprant
    Other Name: MK0524A
    Drug: Comparator: placebo (unspecified)
Detailed Description:

The duration of treatment is 7 days.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111891

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: NCT00111891     History of Changes
Other Study ID Numbers: 2005_032, MK0524A-032
Study First Received: May 26, 2005
Last Updated: July 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
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 16, 2013