At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 enrolled
Drug / intervention
Evolocumab +1 moredrug
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.
Double-blind, Randomized, Multicenter, Placebo-Controlled Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for LDL-C Reduction in Pediatric Subjects 10 to 17 Years of Age With HeFH
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Placebo for Heterozygous Familial Hypercholesterolemia. Completed, enrolled 158 participants across 66 sites in 26 countries.
Detailed Summary
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Finland, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMar 2016
Primary CompletionNov 2019
TodayJul 2026
First PostedMar 19, 2015
Enrollment StartMar 24, 2016
Primary CompletionNov 25, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.3 years ago
Interventions
Evolocumabdrug
Dose of subcutaneous evolocumab every 4 weeks
Placebodrug
Dose of subcutaneous placebo treatment every 4 weeks