Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
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 |
---|---|---|
Dyslipidemia Type 2 Diabetes Mellitus |
Drug: niacin (+) laropiprant Drug: laropiprant Drug: Comparator: niacin Drug: Comparator: placebo (unspecified) |
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: | 20 |
Study Start Date: | September 2007 |
Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
---|---|
A: Experimental
Arm A: ER niacin/laropiprant + Pbo
|
Drug: niacin (+) laropiprant
ER niacin 2 g/laropiprant 40 mg daily for 7 days.
|
B: Experimental
Arm B: ER niacin + Pbo
|
Drug: Comparator: niacin
ER niacin 2 g daily for 7 days.
|
C: Experimental
Arm C: laropiprant + Pbo
|
Drug: laropiprant
laropiprant 40 mg daily for 7 days.
|
D: Placebo Comparator
Arm D: Pbo
|
Drug: Comparator: placebo (unspecified)
Matching placebos for each of the interventions daily for 7 days.
|
Subjects will receive 1 of 4 treatments per period and will eventually receive all four treatments: Treatment A: ER niacin 2 g/laropiprant 40 mg daily + matching Pbo for 7 days; Treatment B: ER niacin 2 g daily + matching Pbo for 7 days; Treatment C: laropiprant 40 mg daily + matching Pbo 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 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00618995 |
Health Authority: | United States: Food and Drug Administration |
Nicotinic Acids Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Metabolic disorder Glucose Metabolism Disorders Niacin 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 |