LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (LAPLACE)
Hyperlipidemia
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Q2W
Placebo Q4W
Evolocumab 70 mg Q2W
Evolocumab 105 mg Q2W
Evolocumab 140 mg Q2W
Evolocumab 280 mg Q4W
Evolocumab 350 mg Q4W
Evolocumab 420 mg Q4W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.