The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

• Status: Terminated
• Trial end date: 2017-04-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bococizumab

Criteria

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.