Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Completed · Phase 2 · Has a placebo group
Conditions studied: Hyperlipidemia
In brief
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Key facts
- Study ID
- NCT01375777
- Run by
- Amgen
- People needed
- 411
- Starts
- 2011-07-06
- Expected to finish
- 2012-03-02
- Last updated by the study team
- 2022-11-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female ≥ 18 to ≤ 75 years of age
- Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
- Framingham risk score of 10% or less
- Fasting triglycerides < 400 mg/dL
You may not qualify if…
- History of coronary heart disease
- New York Heart Association (NYHA) II - IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
Where it is running
- Research Site — Little Rock, Arkansas, United States
- Research Site — Encinitas, California, United States
- Research Site — Inglewood, California, United States
- Research Site — San Diego, California, United States
- Research Site — Tustin, California, United States
- Research Site — DeLand, Florida, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Ponte Vedra, Florida, United States
- Research Site — Sanford, Florida, United States
- Research Site — Decatur, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — Bethesda, Maryland, United States
- Research Site — Brockton, Massachusetts, United States
- Research Site — Brooklyn Center, Minnesota, United States
- Research Site — Las Vegas, Nevada, United States
- Research Site — Endwell, New York, United States
- Research Site — New Windsor, New York, United States
- Research Site — Raleigh, North Carolina, United States
- Research Site — Raleigh, North Carolina, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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