At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
Evolocumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Placebo for Homozygous Familial Hypercholesterolemia. Completed, enrolled 58 participants across 21 sites in 12 countries.
Detailed Summary
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHomozygous Familial Hypercholesterolemia
CountriesBelgium, Canada, Czechia, France, Hong Kong, Italy, Lebanon, Netherlands, New Zealand, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedMay 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedMay 1, 2012
Enrollment StartApr 5, 2012
Primary CompletionJan 31, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.2 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection