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

Organon

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus; Cardiovascular Disorder

Treatments: Drug: ezetimibe (+) simvastatin; Drug: Rosuvastatin; Drug: atorvastatin 10 mg or simvastatin 20 mg; Drug: simvastatin 40 mg or atorvastatin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862251

2009_559 (Other Identifier)

0653A-133

Details and patient eligibility

About

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.

Enrollment: 808 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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808 participants in 3 patient groups

Ezetimibe/simvastatin

Experimental group

Treatment:

Drug: atorvastatin 10 mg or simvastatin 20 mg

Drug: ezetimibe (+) simvastatin

Doubling statin dose

Active Comparator group

Treatment:

Drug: simvastatin 40 mg or atorvastatin 20 mg

Drug: atorvastatin 10 mg or simvastatin 20 mg

Rosuvastatin

Active Comparator group

Treatment:

Drug: atorvastatin 10 mg or simvastatin 20 mg

Drug: Rosuvastatin