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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00651144 |
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.
Condition | Intervention | Phase |
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Hypercholesterolemia Atherosclerosis |
Drug: Ezetimibe + Rosuvastatin Drug: Rosuvastatin Drug: Placebo Drug: Ezetimibe |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | SCH 058235: Assessment of a Multiple-Dose Drug Interaction Between Ezetimibe and Rosuvastatin in Healthy Hypercholesterolemic Subjects |
Enrollment: | 40 |
Study Start Date: | March 2003 |
Study Completion Date: | May 2003 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ezetimibe + Rosuvastatin: Experimental |
Drug: Ezetimibe + Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
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Ezetimibe: Active Comparator |
Drug: Ezetimibe
oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
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Rosuvastatin: Active Comparator |
Drug: Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
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Placebo: Placebo Comparator |
Drug: Placebo
oral tablets; two ezetimibe placebo once daily for 14 days
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03317 |
Study First Received: | March 31, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00651144 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Antilipemic Agents Vascular Diseases Ezetimibe Anticholesteremic Agents |
Arteriosclerosis Healthy Hydroxymethylglutaryl-CoA Reductase Inhibitors Rosuvastatin Hypercholesterolemia Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Vascular Diseases Enzyme Inhibitors Ezetimibe |
Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Rosuvastatin Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |