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NCT02304484 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 770
- Enrollment target
NCT02304484: Completed Phase 3 study, sponsored by Amgen.
NCT02304484 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 770 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02304484, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 770 participants
- Enrollment target
Study Summary
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
Primary Outcome
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser \[AMD\]), including but not limited to, AEs resulti
Interventions
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2014-11-24 |
| Est. Completion | 2018-03-09 |
| Phase | Phase 3 |
What the finished NCT02304484 record still lists
NCT02304484 is an interventional study that assigns participants to a tested intervention. The registered 770 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT02304484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02304484 about?
NCT02304484 is a clinical study titled "Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab". The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
What is the current status of trial NCT02304484?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2014-11-24. Estimated completion is 2018-03-09.
What interventions are being tested in trial NCT02304484?
The interventions under investigation include: Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02304484?
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 NCT02304484's enrollment target sits among peer trials
770 440th of 2000 higher than 1,557 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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