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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 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 10,564 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01975389
The ClinicalTrials.gov registry entry for NCT01975389 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 10,564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01975389 reports 0 study locations.
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.
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