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NCT01849497 · ClinicalTrials.gov registry record · Phase 3
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT01849497: Completed Phase 3 study, sponsored by Amgen.
NCT01849497 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849497, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study 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.
Primary Outcome
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
Interventions
- BIOLOGICAL Evolocumab Pre-filled Syringe
- BIOLOGICAL Evolocumab AI/pen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2013-04-18 |
| Phase | Phase 3 |
What the finished NCT01849497 record still lists
NCT01849497 is an interventional study that assigns participants to a tested intervention. The registered 149 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 (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Evolocumab Pre-filled Syringe is the first listed.
NCT01849497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849497 about?
NCT01849497 is a clinical study titled "Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen". 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.
What is the current status of trial NCT01849497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2013-04-18.
What interventions are being tested in trial NCT01849497?
The interventions under investigation include: Evolocumab Pre-filled Syringe (BIOLOGICAL), Evolocumab AI/pen (BIOLOGICAL).
Who is sponsoring clinical trial NCT01849497?
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 NCT01849497's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 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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