Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

Completed · Phase 2/Phase 3

Conditions studied: Severe Familial Hypercholesterolemia

In brief

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

Key facts

Study ID

NCT01624142

Run by

Amgen

People needed

300

Starts

2012-06-01

Expected to finish

2018-05-11

Last updated by the study team

2024-05-28

Who can join

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

You may qualify if…

• Participated in Study 20110233 (NCT01588496) or another qualifying evolocumab parent protocol and have a diagnosis of familial hypercholesterolemia.
• OR
• Have a diagnosis of familial hypercholesterolemia AND
• Males and females ≥ 12 to ≤ 80 years of age
• Stable low-fat diet and lipid-lowering therapies for at least 4 weeks
• Low-density lipoprotein cholesterol (LDL-C) >= 130 mg/dl (3.4 mmol/L) for subjects without diagnosed coronary heart disease (CHD)/CHD risk equivalent OR LDL-C >= 100 mg/dl (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent OR apheresis patients have no LDL-C entry requirement
• Fasting triglycerides ≤ 400 mg/dL(4.5 mmol/L)
• Body weight of > 40 kg or greater at screening for subjects less than 18 years of age

You may not qualify if…

• New York Heart Failure 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 screening
• Planned cardiac surgery or revascularization
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Hobart, Tasmania, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Brussels, Belgium
• Research Site — La Louvière, Belgium
• Research Site — São Paulo, São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — London, Ontario, Canada
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Brno, Czechia
• Research Site — Hradec Králové, Czechia
• Research Site — Olomouc, Czechia
• Research Site — Prague, Czechia
• Research Site — Uherské Hradiště, Czechia
• Research Site — Dijon, France
• Research Site — Paris, France
• Research Site — Athens, Greece

Full record on ClinicalTrials.gov

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