Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

Launched by ORGANON AND CO · Mar 13, 2009

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Gender

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Eligibility criteria

• 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