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NCT01516879 · ClinicalTrials.gov registry record · Phase 3
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 905
- Enrollment target
NCT01516879: Completed Phase 3 study, sponsored by Amgen.
NCT01516879 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 905 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516879, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 905 participants
- Enrollment target
Study Summary
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
Primary Outcome
Cholesterol was measured by means of ultracentrifugation.
Interventions
- BIOLOGICAL Placebo
- DRUG Ezetimibe
- DRUG Atorvastatin
- OTHER Diet Only
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 905 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2013-10-14 |
| Phase | Phase 3 |
What the finished NCT01516879 record still lists
NCT01516879 is an interventional study that assigns participants to a tested intervention. The registered 905 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01516879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01516879 about?
NCT01516879 is a clinical study titled "Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study". To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
What is the current status of trial NCT01516879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2012-01-05. Estimated completion is 2013-10-14.
What interventions are being tested in trial NCT01516879?
The interventions under investigation include: Placebo (BIOLOGICAL), Ezetimibe (DRUG), Atorvastatin (DRUG), Diet Only (OTHER), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01516879?
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 NCT01516879's enrollment target sits among peer trials
905 347th of 2000 higher than 1,653 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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