At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 149 enrolled
Drug / intervention
Evolocumab Pre-filled Syringe +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 Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen
In Brief
A Phase 3 clinical trial evaluating Evolocumab Pre-filled Syringe and Evolocumab AI/pen for Primary Hypercholesterolemia and Mixed Dyslipidemia. Completed, enrolled 149 participants across 26 sites in 2 countries.
Detailed Summary
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hypercholesterolemia, Mixed Dyslipidemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedMay 8, 2013
Enrollment StartApr 18, 2013
Primary CompletionSep 2, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.2 years ago
Interventions
Evolocumab Pre-filled Syringebiological
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
Evolocumab AI/penbiological
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.