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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
808
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.
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).
Time frame: 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
Time frame: Baseline and Week 6
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
Time frame: Baseline and Week 6
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
Time frame: Baseline and Week 6
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
Time frame: 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)
Time frame: 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)
Time frame: Week 6
Percent Change From Baseline in Total Cholesterol (TC)
Time frame: Baseline and Week 6
Percent Change From Baseline in Triglycerides
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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.
Time frame: Baseline and Week 6
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Week 6
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: Baseline and Week 6
Percent Change From Baseline in LDL-C/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in TC/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time frame: Baseline and Week 6
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)
Time frame: Baseline and Week 6
Percent Change From Baseline in Apo B/Apo A-I Ratio
Time frame: Baseline and Week 6
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline and Week 6