Status:
COMPLETED
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Cardiovascular Disorder
Diabetes Mellitus
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
808 Patients enrolled
Trial Details
Trial ID
NCT00862251
Start Date
April 1 2009
End Date
March 1 2011
Last Update
May 16 2024
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