Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Homozygous Familial Hypercholesterolemia

In brief

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Key facts

Study ID

NCT01588496

Run by

Amgen

People needed

58

Starts

2012-04-05

Expected to finish

2014-01-31

Last updated by the study team

2018-11-29

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ≥ 12 to ≤ 80 years of age
• Diagnosis of homozygous familial hypercholesterolemia
• Stable lipid-lowering therapies for at least 4 weeks
• LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
• Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
• Bodyweight of ≥ 40 kg at screening.

You may not qualify if…

• LDL or plasma apheresis within 8 weeks prior to randomization
• New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
• Planned cardiac surgery or revascularization
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension

Where it is running

• Research Site — New York, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Brussels, Belgium
• Research Site — La Louvière, Belgium
• Research Site — London, Ontario, Canada
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Brno, Czechia
• Research Site — Hradec Králové, Czechia
• Research Site — Uherské Hradiště, Czechia
• Research Site — Dijon, France
• Research Site — Paris, France
• Research Site — New Territories, Hong Kong
• Research Site — Pisa, Italy
• Research Site — Beirut, Lebanon
• Research Site — Amsterdam, Netherlands
• Research Site — Christchurch, New Zealand
• Research Site — Johannesburg, Gauteng, South Africa
• Research Site — Observatory, Western Cape, South Africa
• Research Site — Córdoba, Andalusia, Spain
• Research Site — Lugo, Galicia, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.