LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Completed · Phase 2 · Has a placebo group
Conditions studied: Hyperlipidemia
In brief
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.
Key facts
- Study ID
- NCT01380730
- Run by
- Amgen
- People needed
- 631
- Starts
- 2011-07-01
- Expected to finish
- 2012-04-05
- Last updated by the study team
- 2022-11-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Tucson, Arizona, United States
- Research Site — Malvern, Arkansas, United States
- Research Site — Anaheim, California, United States
- Research Site — Carmichael, California, United States
- Research Site — Newport Beach, California, United States
- Research Site — Roseville, California, United States
- Research Site — Westlake Village, California, United States
- Research Site — Colorado Springs, Colorado, United States
- Research Site — Littleton, Colorado, United States
- Research Site — Daytona Beach, Florida, United States
- Research Site — Green Cove Springs, Florida, United States
- Research Site — Melbourne, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Port Charlotte, Florida, United States
- Research Site — Peoria, Illinois, United States
- Research Site — Hammond, Indiana, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Valparaiso, Indiana, United States
- Research Site — Iowa City, Iowa, United States
- Research Site — Lexington, Kentucky, United States
- Research Site — Auburn, Maine, United States
- Research Site — Bangor, Maine, United States
- Research Site — Portland, Maine, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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