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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00651378 |
Purpose
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Atherosclerosis Coronary Artery Disease |
Drug: Rosuvastatin Drug: Ezetimibe + Atorvastatin Drug: Double Atorvastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of "Switching" to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in Subjects With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease or Diabetes Mellitus Who Have Not Achieved Study Target LDL-C Goal While Dosing With Atorvastatin 10 mg Daily |
| Enrollment: | 87 |
| Study Start Date: | September 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosuvastatin |
Drug: Rosuvastatin
oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
Other Name: Crestor
|
| Active Comparator: Ezetimibe + Atorvastatin |
Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
Other Names:
|
| Active Comparator: Double Atorvastatin |
Drug: Double Atorvastatin
oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
Other Name: Lipitor
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 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: | NCT00651378 History of Changes |
| Other Study ID Numbers: | P03708 |
| Study First Received: | March 31, 2008 |
| Last Updated: | April 1, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Hypercholesterolemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Atorvastatin 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 |