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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Rosuvastatin Calcium; Simvastatin

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