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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00651144 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| Ezetimibe + Rosuvastatin: Experimental |
Drug: Ezetimibe + Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
|
| Ezetimibe: Active Comparator |
Drug: Ezetimibe
oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
|
| Rosuvastatin: Active Comparator |
Drug: Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
|
| Placebo: Placebo Comparator |
Drug: Placebo
oral tablets; two ezetimibe placebo once daily for 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 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 |