Status:
COMPLETED
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Lead Sponsor:
Amgen
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCE...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 5 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2013
Estimated Enrollment :
905 Patients enrolled
Trial Details
Trial ID
NCT01516879
Start Date
January 5 2012
End Date
October 14 2013
Last Update
July 22 2022
Active Locations (96)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States, 35216
2
Research Site
Little Rock, Arkansas, United States, 72205
3
Research Site
Anaheim, California, United States, 92801
4
Research Site
Encinitas, California, United States, 92024