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MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

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.
ClinicalTrials.gov Identifier: NCT00533312
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks Drug: Comparator : niacin / Duraton of Treatment: 4 Weeks Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)
Study Start Date : April 2005
Primary Completion Date : July 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo. [ Time Frame: After 4 weeks ]

Secondary Outcome Measures :
  1. To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo. [ Time Frame: After 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be between the ages of 18 and 70 years
  • Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion Criteria:

  • Patient has a history of peptic ulcer or gout
  • Patient is sensitive to niacin or products containing niacin
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has certain heart disease, cancer, or is HIV positive
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00533312


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00533312     History of Changes
Other Study ID Numbers: 0524A-026
2007_619
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs