At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,324 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 Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
In Brief
A Phase 2 clinical trial evaluating Evolocumab and Standard of care for Hypercholesterolemia. Completed, enrolled 1,324 participants across 187 sites in 18 countries.
Detailed Summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Finland, Germany, Hong Kong, Hungary, Japan, Netherlands, Norway, Singapore, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionJun 2018
TodayJul 2026
First PostedSep 23, 2011
Enrollment StartOct 7, 2011
Primary CompletionJun 20, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.8 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Standard of careother
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes