At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 164 enrolled
Drug / intervention
Evolocumab AMD +1 morebiological
Likely dose
Evolocumab AMD 3.5 mLfrom 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, 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 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.
In Brief
A Phase 3 clinical trial evaluating Evolocumab AMD and Evolocumab AI/pen for Primary Hypercholesterolemia and Mixed Dyslipidemia. Completed, enrolled 164 participants across 27 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 a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hypercholesterolemia, Mixed Dyslipidemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartJul 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedJun 17, 2013
Enrollment StartJul 11, 2013
Primary CompletionNov 15, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.0 years ago
Interventions
Evolocumab AMDbiological
Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
Evolocumab AI/penbiological
Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.