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NCT01879319 · ClinicalTrials.gov registry record · Phase 3
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
NCT01879319: Completed Phase 3 study, sponsored by Amgen.
NCT01879319 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 164 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01879319, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
Study 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).
Primary Outcome
Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.
Interventions
- BIOLOGICAL Evolocumab AI/pen
- BIOLOGICAL Evolocumab AMD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2013-07-11 |
| Phase | Phase 3 |
What the finished NCT01879319 record still lists
NCT01879319 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Evolocumab AI/pen is the first listed.
NCT01879319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01879319 about?
NCT01879319 is a clinical study titled "Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen". 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).
What is the current status of trial NCT01879319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2013-07-11.
What interventions are being tested in trial NCT01879319?
The interventions under investigation include: Evolocumab AI/pen (BIOLOGICAL), Evolocumab AMD (BIOLOGICAL).
Who is sponsoring clinical trial NCT01879319?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01879319's enrollment target sits among peer trials
164 1470th of 2000 higher than 530 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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