A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

Completed · Phase 3 · Has a placebo group

Conditions studied: Heterozygous Familial Hypercholesterolemia

In brief

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.

Key facts

Study ID

NCT01968980

Run by

Pfizer

People needed

370

Starts

2013-10-23

Expected to finish

2016-04-15

Last updated by the study team

2017-06-26

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.
• Heterozygous familial hypercholesterolemia.

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

• Hartford Hospital, JB704 — Hartford, Connecticut, United States
• Best Quality Research, Inc. — Hialeah, Florida, United States
• Medical Research Center — Miami, Florida, United States
• Premier Research Associate, Inc — Miami, Florida, United States
• Columbus Clinical Services, LLC — Miami, Florida, United States
• NewPhase Clinical Trials, Corp. — Miami Beach, Florida, United States
• Om Medical — Las Vegas, Nevada, United States
• The University of North Carolina at Chapel Hill Center for Heart & Vascular Care — Chapel Hill, North Carolina, United States
• The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic — Chapel Hill, North Carolina, United States
• Metabolic and Atherosclerosis Research Center — Cincinnati, Ohio, United States
• Oklahoma Heart Hospital Physicians — Oklahoma City, Oklahoma, United States
• Oklahoma Heart Hospital Research Foundation — Oklahoma City, Oklahoma, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• OnSite Clinical Solutions, LLC — Gaffney, South Carolina, United States
• Galenos Research — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Pioneer Research Solutions, Inc. — Houston, Texas, United States
• Pioneer Research Solutions, Inc. — Sugar Land, Texas, United States
• Focus Clinical Research, LLC — Draper, Utah, United States
• Burke Internal Medicine & Research — Burke, Virginia, United States
• SHAT in Cardiology EAD — Pleven, Bulgaria
• UMHAT "Sveti Georgi" EAD, Clinic of Cardiology — Plovdiv, Bulgaria
• Second MHAT - Sofia EAD — Sofia, Bulgaria
• IMD Medical Group — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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