|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Ezetimibe + Rosuvastatin |
Drug: Ezetimibe + Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
Other Names:
|
| Active Comparator: Ezetimibe |
Drug: Ezetimibe
oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
Other Names:
|
| Active Comparator: Rosuvastatin |
Drug: Rosuvastatin
oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
Other Name: Crestor
|
| Placebo Comparator: Placebo |
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: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00651144 History of Changes |
| Other Study ID Numbers: | P03317 |
| Study First Received: | March 31, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Atherosclerosis Hypercholesterolemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin |
Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |