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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111891
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: niacin (+) laropiprant Drug: Comparator: placebo (unspecified) Phase 2

Detailed Description:
The duration of treatment is 7 days.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2005
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Acute cutaneous symptoms induced by niacin for 7 days. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111891

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00111891     History of Changes
Other Study ID Numbers: 0524-032
First Posted: May 27, 2005    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

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