Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
Phase 3
Completed
- Conditions
- Cardiovascular DisorderDiabetes Mellitus
- Interventions
- Registration Number
- NCT00862251
- Lead Sponsor
- Organon and Co
- 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 patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 808
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doubling statin dose atorvastatin 10 mg or simvastatin 20 mg - Ezetimibe/simvastatin atorvastatin 10 mg or simvastatin 20 mg - Ezetimibe/simvastatin ezetimibe (+) simvastatin - Doubling statin dose simvastatin 40 mg or atorvastatin 20 mg - Rosuvastatin atorvastatin 10 mg or simvastatin 20 mg - Rosuvastatin Rosuvastatin -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). Baseline and Week 6
- Secondary Outcome Measures
Name Time Method In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin Baseline and Week 6 Percent Change From Baseline in TC/HDL-C Ratio Baseline and Week 6 Percent Change From Baseline Apolipoprotein A-I (Apo A-I) Baseline and Week 6 In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) Week 6 Percent Change From Baseline in Total Cholesterol (TC) Baseline and Week 6 Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Baseline and Week 6 Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Baseline and Week 6 In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin Baseline and Week 6 Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin Baseline and Week 6 Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) Week 6 Percent Change From Baseline in Triglycerides Baseline and Week 6 Percent Change From Baseline in LDL-C/HDL-C Ratio Baseline and Week 6 Percent Change From Baseline in Non-HDL-C/HDL-C Ratio Baseline and Week 6 Percent Change From Baseline in Apolipoprotein B (Apo B) Baseline and Week 6 Percent Change From Baseline in Apo B/Apo A-I Ratio Baseline and Week 6 Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Baseline and Week 6 In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) Week 6