A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose

0653A-133

The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

2009-04-01

2011-03-01

2011-03-01

Completed

Early phase I

808

Inclusion Criteria: * Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimibe + fluvastatin * Patient is willing to go on a cholesterol and glucose lowering diet for the duration of the study * Patient is willing to remain abstinent or use birth control for the duration of the study * Patient has Diabetes Mellitus with cardiovascular disease Exclusion Criteria: * Patient has sensitivity to certain common statin drugs * Patient is Asian and would not be able to start taking the higher doses of rosuvastatin necessary for the study design * Patient consumes more than 2 alcoholic drinks per day * Patient is pregnant or breast-feeding * Patient has been treated with other investigational drugs within 30 days of first visit * Patient is currently on prohibited doses of the following statin drugs: rosuvastatin, simvastatin, atorvastatin, and pravastatin * Patient has congestive heart failure * Patient has uncontrolled high blood pressure * Patient has kidney disease * Patient has uncontrolled endocrine or metabolic disease which are known to possibly increase blood lipoproteins * Patient has diabetes mellitus that is not well controlled * Patient is human immunodeficiency virus (HIV) positive * Patient is currently taking medications that inhibit Cytochrome P450 3A4 (CYP3A4) * Patient is currently taking therapies that would increase the risk of muscle weakness * Patient has been taking certain over- the-counter lipid-lowering agents within 6 weeks prior to visit 1 * Patient is currently taking psyllium or other fiber-based laxatives

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 808, 'type': 'ACTUAL'}}

2024-05-16