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NCT01975389 · ClinicalTrials.gov registry record · Phase 3
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10,564
- Enrollment target
NCT01975389: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT01975389 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 10,564 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1270% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01975389, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10,564 participants
- Enrollment target
Study Summary
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).
Primary Outcome
Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death \[defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes\] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revas
Interventions
- DRUG Placebo
- DRUG bococizumab (PF-04950615)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,564 participants |
| Start Date | 2013-10-29 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 3 |
Why NCT01975389 stopped before completion
NCT01975389 is an interventional study that assigns participants to a tested intervention. Its 10,564 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1270% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01975389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01975389 about?
NCT01975389 is a clinical study titled "The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects". This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who ...
What is the current status of trial NCT01975389?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10,564 participants. The study started on 2013-10-29. Estimated completion is 2017-04-03.
What interventions are being tested in trial NCT01975389?
The interventions under investigation include: Placebo (DRUG), bococizumab (PF-04950615) (DRUG).
Who is sponsoring clinical trial NCT01975389?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01975389's enrollment target sits among peer trials
10,564 25th of 2000 higher than 1,976 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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