MK0524A Clinical Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00533312
First received: September 19, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

No publications provided

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
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 April 21, 2014