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

NCT01968954

Run by

Pfizer

People needed

711

Starts

2013-10-01

Expected to finish

2016-04-01

Last updated by the study team

2017-05-17

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

• Cardiovascular Associates of the Southeast, LLC — Birmingham, Alabama, United States
• Southwest Heart Group — Tucson, Arizona, United States
• ARA-Arizona Research Associates — Tucson, Arizona, United States
• Diagnamics, Inc. — Encinitas, California, United States
• Encompass Clinical Research North Coast — Encinitas, California, United States
• MD Studies, Inc. — Fountain Valley, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• Prime Care Clinical Research — Laguna Hills, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• San Diego Family Care — San Diego, California, United States
• St. Joseph's Medical Associates — Stockton, California, United States
• Orange County Research Center — Tustin, California, United States
• Clinical Research Advantage, Inc./Cassidy Medical Group - Vista — Vista, California, United States
• Elite Clinical Trials — Wildomar, California, United States
• Expresscare Clinical Research — Colorado Springs, Colorado, United States
• Soundview Medical Associates — Norwalk, Connecticut, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates — Jacksonville, Florida, United States
• Care Partners Clinical Research, LLC — Jacksonville, Florida, United States
• Prestige Clinical Research Center Inc — Miami, Florida, United States
• Edgewater Medical Research — New Smyrna Beach, Florida, United States
• Gulfcoast Medical Research Center, LLC — Tampa, Florida, United States
• Fellows Research Alliance, Inc. — Savannah, Georgia, United States
• SouthCoast Medical Group — Savannah, Georgia, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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