Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
Key facts
- Study ID
- NCT01516879
- Run by
- Amgen
- People needed
- 905
- Starts
- 2012-01-05
- Expected to finish
- 2013-10-14
- Last updated by the study team
- 2022-07-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has provided informed consent.
- Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:
- < 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent
- < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
- OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
- Fasting triglycerides ≤ 400 mg/dL
You may not qualify if…
- New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular ejection fraction < 30%
- Uncontrolled cardiac arrhythmia
- 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
- Uncontrolled hypertension
Where it is running
- Research Site — Little Rock, Arkansas, United States
- Research Site — Anaheim, California, United States
- Research Site — Encinitas, California, United States
- Research Site — Spring Valley, California, United States
- Research Site — Westlake Village, California, United States
- Research Site — DeLand, Florida, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Ponte Vedra, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Savannah, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — Auburn, Maine, United States
- Research Site — Bethesda, Maryland, United States
- Research Site — Chevy Chase, Maryland, United States
- Research Site — Columbia, Maryland, United States
- Research Site — Brockton, Massachusetts, United States
- Research Site — Saint Paul, Minnesota, United States
- Research Site — Olive Branch, Mississippi, United States
- Research Site — Las Vegas, Nevada, United States
- Research Site — Endwell, New York, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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