An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00111891
First received: May 26, 2005
Last updated: July 30, 2008
Last verified: July 2008
  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:


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
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
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 ClinicalTrials.gov identifier: NCT00111891

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 July 10, 2014