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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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).

Key facts

Study ID

NCT01975389

Run by

Pfizer

People needed

10564

Starts

2013-10-29

Expected to finish

2017-04-03

Last updated by the study team

2019-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• North Alabama Research Center, LLC — Athens, Alabama, United States
• Central Alabama Research — Birmingham, Alabama, United States
• Clinical Research Advantage, Inc./Simon Williamson Clinic — Birmingham, Alabama, United States
• The Kirklin Clinic — Birmingham, Alabama, United States
• Birmingham Heart Clinic, P.C. — Birmingham, Alabama, United States
• University of Alabama at Birmingham (Drug Shipment) — Birmingham, Alabama, United States
• Appalachian Cardiovascular Associates — Fort Payne, Alabama, United States
• Fundamental Research, LLC — Gulf Shores, Alabama, United States
• Avant Research Associates, LLC — Guntersville, Alabama, United States
• Boyett Health Services — Hamilton, Alabama, United States
• The Office of Saadat Ansari MD LLC — Huntsville, Alabama, United States
• CB Flock Research Corporation — Mobile, Alabama, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• Phoenix Heart, PLLC — Glendale, Arizona, United States
• Arrowhead Internal Medicine — Glendale, Arizona, United States
• Clinical Research Advantage, Inc./Family Practice Specialists, Ltd. — Phoenix, Arizona, United States
• Cochise Clinical Research — Sierra Vista, Arizona, United States
• Clinical Research Advantage, Inc. (Administrative Mailing Only) — Tempe, Arizona, United States
• Southwest Heart Group — Tucson, Arizona, United States
• Arizona Endocrine and Rheumatology Associates — Tucson, Arizona, United States
• Arkansas Heart Hospital Clinic — Little Rock, Arkansas, United States
• Arkansas Site Management Services, LLC — Little Rock, Arkansas, United States
• Cardiology Consultants of Orange County Medical Group, Inc. — Anaheim, California, United States
• Premier Valley Medical Group — Bakersfield, California, United States
• Ernest Hendrix, MD, PC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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