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

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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).

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.

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
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148 E. Hersey St.
Ashland, Oregon 97520
541-488-9325
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30 Pointe Circle
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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