Inclusion criteria†| |
---|---|
COMBO I | COMBO II |
Patients with hypercholesterolemia and established CHD or CHD risk equivalents# with LDL-C poorly controlled with a maximally tolerated daily dose of statin with or without other LLT, both at stable dose for at least 4 weeks (6 weeks for fenofibrate) prior to the screening visit (week −2) | Patients with hypercholesterolemia and established CHD or CHD risk equivalents# with LDL-C poorly controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (week −3) |
Baseline entry criteria: LDL-C levels depending on history of documented CVD: | Baseline entry criteria: LDL-C levels depending on history of documented CVD: |
• LDL-C ≥70 mg/dL (≥1.81 mmol/L) at the screening visit with a history of documented CVD | • LDL-C ≥70 mg/dL (≥1.81 mmol/L) at the screening visit with a history of documented CVD |
• LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit in patients without history of documented CVD | • LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit in patients without history of documented CVD |
Exclusion criteria †| |
COMBO I | COMBO II |
Age <18Â years | Age <18Â years |
Fasting serum triglycerides >400Â mg/dL (>4.52Â mmol/L) during the screening period | Fasting serum triglycerides >400Â mg/dL (>4.52Â mmol/L) during the screening period |
Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose | Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose |
Use of fibrates, other than fenofibrate, within 6 weeks prior to the screening visit (week −2) | Use of concomitant meds |
 | • Ezetimibe, omega-3 fatty acid (at doses ≥1,000 mg daily), nicotinic acid, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (week −3) |
 | • Use of fibrates in the past 6 weeks prior to screening visit (week −3) |