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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00536510 |
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia Hyperlipidemia |
Drug: laropiprant/niacin (MK0524A) Drug: Comparator: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia |
Enrollment: | 646 |
Study Start Date: | April 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
laropiprant/niacin (MK0524A)
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Drug: laropiprant/niacin (MK0524A)
Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization |
2: Placebo Comparator
placebo
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Drug: Comparator: placebo
Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization. |
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: | 2007_621, MK0524A-048 |
Study First Received: | September 26, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00536510 History of Changes |
Health Authority: | China: Ministry of Health |
High Cholesterol Excess lipids |
Nicotinic Acids Combined Hyperlipidemia, Familial Niacinamide Metabolic Diseases Hyperlipidemias Hyperlipidemia, Familial Combined |
Niacin Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Hyperlipidemias Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |