At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,681 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
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Standard of Care for Hyperlipidemia and Mixed Dyslipidemia. Completed, enrolled 3,681 participants across 363 sites in 25 countries.
Detailed Summary
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia and Mixed Dyslipidemia
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionMay 2018
TodayJul 2026
First PostedMay 16, 2013
Enrollment StartApr 23, 2013
Primary CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.1 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of Caredrug
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes