Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With 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, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Key facts

Study ID

NCT01968967

Run by

Pfizer

People needed

2139

Starts

2013-10-29

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 > 70 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 of procedures during the past 30 days.
• Congestive heart failure NYHA class IV.
• Poorly controlled hypertension.

Where it is running

• North Alabama Research Center, LLC — Athens, Alabama, United States
• The Kirklin Clinic — Birmingham, Alabama, United States
• Alabama Internal Medicine, P.C. — Birmingham, Alabama, United States
• Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham — Birmingham, Alabama, United States
• Heart Center Research, Llc — Huntsville, Alabama, United States
• Radiant Research Incorporated — Chandler, Arizona, United States
• Advanced Research Associates — Glendale, Arizona, United States
• Arizona Center For Internal Medicine — Mesa, Arizona, United States
• Holland Center for Family Health — Peoria, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Phoenix Clinical — Phoenix, Arizona, United States
• Desert Sun Clinical Research, LLC — Tucson, Arizona, United States
• Advanced Arizona Clinical Research — Tucson, Arizona, United States
• Care Clinical Research Corporation — Banning, California, United States
• Med Center — Carmichael, California, United States
• Med Investigations — Fair Oaks, California, United States
• California Heart Specialists — Huntington Beach, California, United States
• Alia Clinical Research, Inc. — Huntington Park, California, United States
• Downtown L.A. Research Center, Inc. — Los Angeles, California, United States
• Richard S. Cherlin, M.D. — Los Gatos, California, United States
• California Medical Research Associates Inc. — Northridge, California, United States
• Arch Health Partners Clinical Research Department — Poway, California, United States
• Clinical Trials Research — Sacramento, California, United States
• Northern California Research — Sacramento, California, United States
• Ernest L. Hendrix, MD, PC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.