At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 39 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 Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Low-density Lipoprotein Cholesterol (LDL-C) Apheresis for Hypercholesterolemia. Completed, enrolled 39 participants across 17 sites in 8 countries.
Detailed Summary
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Czechia, France, Germany, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartDec 2015
Primary CompletionSep 2016
Study CompletionJan 2017
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartDec 21, 2015
Primary CompletionSep 1, 2016
Study CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection once every 2 weeks
Low-density Lipoprotein Cholesterol (LDL-C) Apheresisprocedure
Participants received apheresis for LDL-C according the their physician's prescription and local custom.