LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered
 every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from
 baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
Inclusion Criteria:

 -  Male or female ≥ 18 to ≤ 80 years of age

 -  On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4
 weeks

 -  Fasting LDL-C ≥ 85 mg/dL

 -  Fasting triglycerides ≤ 400 mg/dL

 Exclusion Criteria:

 -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
 coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

 -  Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated
 Hemoglobin (HbA1c) > 8.5%)

 -  Uncontrolled hypertension

 -  New York Heart Association (NYHA) III or IV heart failure, or known left ventricular
 ejection fraction < 30%

 -  Uncontrolled cardiac arrhythmia