Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

• Status: Completed
• Trial end date: 2014-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Evolocumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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