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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00376584 |
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
Condition | Intervention | Phase |
---|---|---|
Hypercholesteremia Hyperlipidemia |
Drug: niacin (+) laropiprant Drug: Comparator : niacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin |
Enrollment: | 825 |
Study Start Date: | September 2006 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_504, MK0524A-023 |
Study First Received: | September 14, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00376584 |
Health Authority: | United States: Food and Drug Administration |
Primary Hypercholesteremia Mixed Hyperlipidemia |
Nicotinic Acids Metabolic Diseases Hyperlipidemias Hyperlipidemia, Familial Combined Metabolic disorder |
Niacin Combined hyperlipidemia, familial Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Antilipemic Agents Therapeutic Uses Physiological Effects of Drugs Micronutrients Cardiovascular Agents Pharmacologic Actions |