Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

Key facts

Study ID

NCT02100514

Run by

Pfizer

People needed

746

Starts

2014-10-28

Expected to finish

2017-07-10

Last updated by the study team

2018-07-31

Who can join

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

You may qualify if…

• Treated with a statin
• Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL
• High or very high risk of incurring a cardiovascular event

You may not qualify if…

• Pregnant or breastfeeding females
• Cardiovascular or cerebrovascular event or procedure within 90 days
• Congestive heart failure NYHA class IV
• Poorly controlled hypertension

Where it is running

• Advanced Cardiovascular, LLC, Research — Auburn, Alabama, United States
• Clinical Research Advantage, Inc./Family Practice Specialists, Ltd. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc./Family Practice Specialists, LTD — Phoenix, Arizona, United States
• Radiant Research, Inc. — Tucson, Arizona, United States
• Radiant Research, Inc — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• The Office of Larry Watkins, MD — Little Rock, Arkansas, United States
• American Institute of Research — Los Angeles, California, United States
• lntermed Group — Los Angeles, California, United States
• IMD Medical Group — Los Angeles, California, United States
• The Office of Lucita M. Cruz, M.D., Inc. — Norwalk, California, United States
• Superior Research, LLC — Sacramento, California, United States
• Superior Research ,LLC — Sacramento, California, United States
• Radiant Research, Inc. — Santa Rosa, California, United States
• Orange County Research Center — Tustin, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Clinical Research Advantage, Inc. / Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• Boca Raton Clinical Research Associates — Boca Raton, Florida, United States
• BRCR Medical Center, Inc. — Boca Raton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Linfritz Research Institute Inc. — Coral Gables, Florida, United States
• Florida Health Center — Fort Lauderdale, Florida, United States
• Advanced Cardiovascular, LLC Research — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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