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| Sponsors and Collaborators: |
Schering-Plough 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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
| Rosuvastatin: Experimental |
Drug: Rosuvastatin
oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
|
| Ezetimibe + Atorvastatin: Active Comparator |
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)
|
| Double Atorvastatin: Active Comparator |
Drug: Double Atorvastatin
oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
|
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: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P03708 |
| Study First Received: | March 31, 2008 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651378 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Metabolic Diseases Heart Diseases Hyperlipidemias Antilipemic Agents Myocardial Ischemia Vascular Diseases Diabetes Mellitus Ezetimibe Anticholesteremic Agents |
Arteriosclerosis Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Rosuvastatin Metabolic Disorder Hypercholesterolemia Atorvastatin Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
|
Atherosclerosis Antimetabolites Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Ezetimibe Arteriosclerosis Rosuvastatin Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Arterial Occlusive Diseases Hyperlipidemias |
Heart Diseases Metabolic Diseases Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Coronary Artery Disease Atorvastatin Lipid Metabolism Disorders |