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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00536237 |
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.
Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.
Condition | Intervention | Phase |
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Flushing |
Drug: Comparator: niacin / Duration of Treatment: 17 Weeks Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients |
Estimated Enrollment: | 450 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2004 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2007_618 |
Study First Received: | September 26, 2007 |
Last Updated: | September 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00536237 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Vasodilator Agents Niacinamide Vitamin B Complex Antilipemic Agents Trace Elements Cardiovascular Agents |
Signs and Symptoms Nicotinic Acids Vitamins Flushing Micronutrients Niacin |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs Cardiovascular Agents |
Pharmacologic Actions Signs and Symptoms Therapeutic Uses Vitamins Flushing Micronutrients Niacin |