At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 770 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 Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
In Brief
A Phase 3 clinical trial evaluating Evolocumab for Hypercholesterolemia. Completed, enrolled 770 participants across 126 sites in 29 countries.
Detailed Summary
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedDec 2014
Primary CompletionMar 2018
TodayJul 2026
First PostedDec 2, 2014
Enrollment StartNov 24, 2014
Primary CompletionMar 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.6 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection once a month