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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/15/2016
Start Date:October 2013
End Date:April 2016

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A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- Pregnant or breastfeeding females.

- Cardiovascular or cerebrovascular event of procedures during the past 30 days.

- Congestive heart failure NYHA class IV.

- Poorly controlled hypertension.
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Burke, Virginia 22015
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Dallas, Texas 75251
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Draper, Utah 84020
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Gaffney, South Carolina 29340
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hialeah, Florida 33016
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Houston, Texas 77098
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Las Vegas, Nevada 89119
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Los Angeles, California 90020
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286 Westward Drive
Miami, Florida 33144
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Miami, Florida 33165
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Miami, Florida 33174
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Miami Beach, Florida 33140
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Oklahoma City, Oklahoma 73120
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Oklahoma City, Oklahoma 73120
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Oklahoma City, Oklahoma 73120
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Sugar Land, Texas 77479
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