Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
Condition: Cardiovascular Disorder; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus
Intervention: ezetimibe (+) simvastatin; simvastatin 40 mg or atorvastatin 20 mg; Rosuvastatin; atorvastatin 10 mg or simvastatin 20 mg
Intervention description: ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.; simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.; rosuvastatin 10 mg tablets, taken once daily for six weeks.; All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 808.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: cardiovascular disorder

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.
    

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