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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00618995 |
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 specific metabolite (which is a marker of in vivo platelet reactivity).
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Comparator: ER niacin (+) laropiprant Drug: Comparator: ER 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 Type 2 Diabetes |
Enrollment: | 26 |
Study Start Date: | September 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Arm A: ER niacin/laropiprant + Placebo to laropiprant
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Drug: Comparator: ER niacin (+) laropiprant
ER niacin 2 g/ laropiprant 40 mg daily for 7 days.
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B: Experimental
Arm B: ER niacin + Placebo to laropiprant
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Drug: Comparator: ER niacin
ER niacin 2 g daily for 7 days.
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C: Experimental
Arm C: laropiprant + Placebo to ER Niacin/laropiprant
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Drug: Comparator: laropiprant
laropiprant 40 mg daily for 7 days.
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D: Placebo Comparator
Arm D: 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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Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments:
Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days
Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7 days
Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days
Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period
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_508, MK0524A-079 |
Study First Received: | February 8, 2008 |
Results First Received: | December 5, 2008 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00618995 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Vasodilator Agents Vitamin B Complex Metabolic Diseases Niacinamide Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Trace Elements |
Cardiovascular Agents Nicotinic Acids Vitamins Diabetes Mellitus, Type 2 Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Niacin |
Antimetabolites Vasodilator Agents Vitamin B Complex Metabolic Diseases Niacinamide Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs Diabetes Mellitus |
Endocrine System Diseases Cardiovascular Agents Pharmacologic Actions Nicotinic Acids Vitamins Therapeutic Uses Diabetes Mellitus, Type 2 Micronutrients Glucose Metabolism Disorders Niacin |