At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 163 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.
Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)
In Brief
A Phase 3 clinical trial evaluating Evolocumab for Familial Hypercholesterolemia. Completed, enrolled 163 participants across 46 sites in 23 countries.
Detailed Summary
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Hypercholesterolemia
CountriesAustralia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Greece, Hungary, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartSep 2016
Primary CompletionJun 2021
TodayJul 2026
First PostedDec 9, 2015
Enrollment StartSep 10, 2016
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.6 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection