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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00769132 |
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: Comparator: niacin + laropiprant Drug: Comparator: niacin Drug: Comparator: laropiprant Drug: Comparator: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Hypercholesterolemia |
Enrollment: | 26 |
Study Start Date: | August 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
ER niacin/laropiprant + Placebo to laropiprant
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Drug: Comparator: niacin + laropiprant
ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days
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B: Active Comparator
ER niacin + Placebo to laropiprant
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Drug: Comparator: niacin
ER niacin 2 g tablet once daily for 7 days
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C: Experimental
laropiprant + Placebo to ER niacin/laropiprant
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Drug: Comparator: laropiprant
laropiprant 40 mg once daily for 7 days
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D: Placebo Comparator
Placebo
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Drug: Comparator: placebo
matching placebo tablets for each of the interventions once daily for 7 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_561, MK0524A-075 |
Study First Received: | October 7, 2008 |
Results First Received: | October 30, 2008 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00769132 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Vasodilator Agents Vitamin B Complex Hyperlipidemias Metabolic Diseases Niacinamide Antilipemic Agents Trace Elements Cardiovascular Agents |
Nicotinic Acids Vitamins Micronutrients Hypercholesterolemia Metabolic Disorder Niacin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Vitamin B Complex Hyperlipidemias Metabolic Diseases Niacinamide Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs |
Cardiovascular Agents Pharmacologic Actions Nicotinic Acids Vitamins Therapeutic Uses Micronutrients Hypercholesterolemia Niacin Dyslipidemias Lipid Metabolism Disorders |