Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	12 - 80
Updated:	12/1/2018
Start Date:	April 5, 2012
End Date:	January 31, 2014

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

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

Study Masking:

Part A: Open Label Part B: Double Blind

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

We found this trial at

sites

Clinical Trial Facility in Bruxelles

Bruxelles,

4719

from

Bruxelles,