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Sponsors and Collaborators: |
Merck Schering-Plough |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00652301 |
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
Condition | Intervention | Phase |
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Cholesterol |
Drug: ezetimibe Drug: Comparator: Placebo (unspecified) Drug: simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, 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 Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol |
Enrollment: | 40 |
Study Start Date: | July 2003 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ezetimibe 10 mg tablet plus simvastatin 20 mg tablet
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Drug: ezetimibe
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Drug: simvastatin
simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
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2: Active Comparator
ezetimibe 10 mg tablet
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Drug: ezetimibe
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.
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3: Active Comparator
simvastatin 20 mg tablet
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Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.
Drug: simvastatin
simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
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4: Placebo Comparator
matching placebo
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Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.
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Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_559, MK0653-050 |
Study First Received: | March 31, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00652301 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Simvastatin Ezetimibe |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |