Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
Completed · Phase 3 · Has a placebo group
Conditions studied: Hyperlipidemia
In brief
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
Key facts
- Study ID
- NCT02135029
- Run by
- Pfizer
- People needed
- 184
- Starts
- 2014-06-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2017-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hyperlipidemia
- Statin Intolerant
- Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL
You may not qualify if…
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Severe or life-threatening adverse events with past use of statins
- Poorly controlled hypertension
Where it is running
- Creekside Endocrine Associates, PC — Denver, Colorado, United States
- Bridgeport Hospital — Bridgeport, Connecticut, United States
- Watson Clinic Center for Research, Inc. (for Drug Shipment only) — Lakeland, Florida, United States
- Cardiovascular Research Center Of South Florida — Miami, Florida, United States
- St. Johns Center for Clinical Research — Ponte Vedra, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- East-West Medical Research Institute — Honolulu, Hawaii, United States
- NorthShore University HealthSystem - Evanston Hospital — Evanston, Illinois, United States
- Health Care Centers of Illinois Mokena Medical Commons — Mokena, Illinois, United States
- Advocate Medical Group Cardiology — Normal, Illinois, United States
- Advocate Medical Group Midwest Heart Specialists — Park Ridge, Illinois, United States
- Prairie Education & Research Cooperative (Administrative) — Springfield, Illinois, United States
- Prairie Heart Institute — Springfield, Illinois, United States
- St. John's Hospital — Springfield, Illinois, United States
- The University of Iowa - College of Public Health - Preventive Intervention Center — Iowa City, Iowa, United States
- The Iowa Clinic, PC — West Des Moines, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Crescent City Clinical Research Center — Metairie, Louisiana, United States
- Allina Health System, dba Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
- Dayton Heart Center — Dayton, Ohio, United States
- Clinical and Translational Research Center, Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
- Berks Cardiologists, Ltd. — Wyomissing, Pennsylvania, United States
Full record on ClinicalTrials.gov
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