The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | October 29, 2013 |
| End Date: | February 17, 2017 |
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), 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 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).
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).
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical
profile and the evolving treatment and market landscape for lipid-lowering agents. These
indicated that bococizumab was not likely to provide value to patients, physicians, or
shareholders. The decision was not based on a recommendation by the independent Data
Monitoring Committee to stop the program.
profile and the evolving treatment and market landscape for lipid-lowering agents. These
indicated that bococizumab was not likely to provide value to patients, physicians, or
shareholders. The decision was not based on a recommendation by the independent Data
Monitoring Committee to stop the program.
Inclusion Criteria:
- Must be on background lipid lowering treatment.
- Must be at high risk of a CV event.
- Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).
Exclusion Criteria:
- Planned coronary (PCI or CABG) or other arterial revascularization.
- New York Heart Association Class IV congestive heart failure or left ventricular
ejection fraction < 25% by cardiac imaging.
- Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
formula or with end state renal disease on dialysis.
- History of hemorrhagic stroke.
- Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
We found this trial at
512
sites
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Chicago, Illinois 60631
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1200 Druid Road South
Clearwater, Florida 33756
Clearwater, Florida 33756
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