At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Evolocumabbiological
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.
A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Evolocumab for Severe Familial Hypercholesterolemia. Completed, enrolled 300 participants across 44 sites in 18 countries.
Detailed Summary
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Familial Hypercholesterolemia
CountriesAustralia, Belgium, Brazil, Canada, Czechia, France, Greece, Hong Kong, Israel, Italy, Japan, Lebanon, Netherlands, New Zealand, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionMay 2018
TodayJul 2026
First PostedJun 20, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 11, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.0 years ago
Interventions
Evolocumabbiological
Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).