NCT01588496

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Study Masking: Part A: Open Label Part B: Double Blind

Conditions

• Homozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection
DRUG	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2012-04-05
• Primary completion: 2014-01-31
• Completion: 2014-01-31
• First posted: 2012-05-01
• Last updated: 2018-11-29
• Results posted: 2015-10-02

Locations

21 sites across 12 countries: United States, Belgium, Canada, Czechia, France, Hong Kong, Italy, Lebanon, Netherlands, New Zealand, South Africa, Spain