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Tolerability of MK0524A Versus Niacin Extended-Release

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00378833
First received: September 20, 2006
Last updated: February 26, 2008
Last verified: February 2008
History of Changes
  Purpose

This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.


Condition Intervention Phase
Hypercholesterolemia
Hyperlipidemia
 Drug: niacin (+) laropiprant
Drug: niacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Global Flushing Severity Score (GFSS) over 16 weeks

Secondary Outcome Measures:
  • Safety/tolerability

Enrollment: 1300
Study Start Date: July 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: niacin (+) laropiprant
    Duration of Treatment: 18 Weeks
    Other Name: MK0524A
    Drug: niacin
    Duration of Treatment: 18 Weeks
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion Criteria:

  • Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
  • Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
  • Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378833

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00378833     History of Changes
Other Study ID Numbers: 2006_529
Study First Received: September 20, 2006
Last Updated: February 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Primary Hypercholesterolemia or Mixed Hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Niacinamide
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 June 18, 2013