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NCT01439880 · ClinicalTrials.gov registry record · Phase 2
Open Label Study of Long Term Evaluation Against LDL-C Trial
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,324
- Enrollment target
NCT01439880: Completed Phase 2 study, sponsored by Amgen.
NCT01439880 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 1,324 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (895% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439880, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,324 participants
- Enrollment target
Study Summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Primary Outcome
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Interventions
- OTHER Standard of care
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,324 participants |
| Start Date | 2011-10-07 |
| Est. Completion | 2018-06-20 |
| Phase | Phase 2 |
What the finished NCT01439880 record still lists
NCT01439880 is an interventional study that assigns participants to a tested intervention. Its 1,324 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (895% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT01439880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439880 about?
NCT01439880 is a clinical study titled "Open Label Study of Long Term Evaluation Against LDL-C Trial". The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
What is the current status of trial NCT01439880?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,324 participants. The study started on 2011-10-07. Estimated completion is 2018-06-20.
What interventions are being tested in trial NCT01439880?
The interventions under investigation include: Standard of care (OTHER), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01439880?
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 NCT01439880's enrollment target sits among peer trials
1,324 13th of 2000 higher than 1,988 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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