TerminatedPhase 3

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

Stopped: See Detailed Description

United States10,564 participantsStarted 2013-10-29

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event

Timeframe: From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)

Trial details

NCT IDNCT01975389

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-03

Results submitted2018-03-21