At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 5,035 enrolled
Drug / intervention
Evolocumabbiological
Likely dose
Evolocumab 140 mgfrom 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, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
In Brief
A Phase 3 clinical trial evaluating Evolocumab for Dyslipidemia. Completed, enrolled 5,035 participants across 198 sites in 7 countries.
Detailed Summary
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesCzechia, Hungary, Poland, Russia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionMar 2022
TodayJul 2026
First PostedAug 16, 2016
Enrollment StartSep 2, 2016
Primary CompletionMar 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.9 years ago
Interventions
Evolocumabbiological
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.