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MK0524A Clinical Efficacy Study
This study has been completed.
First Received: September 19, 2007   No Changes Posted
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00533312
  Purpose

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


Condition Intervention 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 II

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Merck:

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

Estimated Enrollment: 360
Study Start Date: February 2005
Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533312

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Study ID Numbers: 2007_619
Study First Received: September 19, 2007
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00533312     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Nicotinic Acids
Niacinamide
Metabolic Diseases
Hyperlipidemias
Niacin
 Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009



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