Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Key facts

Study ID

NCT01763827

Run by

Amgen

People needed

615

Starts

2013-01-21

Expected to finish

2013-10-29

Last updated by the study team

2022-11-08

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
• National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
• Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

You may not qualify if…

• History of coronary heart disease
• New York Heart Association (NYHA) III or IV heart failure
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
• Uncontrolled hypothyroidism or hyperthyroidism

Where it is running

• Research Site — Chandler, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Carmichael, California, United States
• Research Site — Encinitas, California, United States
• Research Site — San Diego, California, United States
• Research Site — Tustin, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Ponte Vedra, Florida, United States
• Research Site — Sanford, Florida, United States
• Research Site — Boise, Idaho, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Brockton, Massachusetts, United States
• Research Site — Edina, 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 — New Windsor, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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