At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 331 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.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Placebo for Hyperlipidemia. Completed, enrolled 331 participants across 39 sites in 14 countries.
Detailed Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Canada, France, Germany, Hong Kong, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionNov 2013
Study CompletionDec 2013
TodayJul 2026
First PostedJan 9, 2013
Enrollment StartFeb 7, 2013
Primary CompletionNov 27, 2013
Study CompletionDec 19, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection