The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects



Status:Terminated
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:October 29, 2013
End Date:February 17, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular
death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization
in high risk subjects who are receiving background lipid lowering therapy and have
cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL
(3.4 mmol/L).

The trial was terminated prematurely on November 1, 2016, due to the emerging clinical
profile and the evolving treatment and market landscape for lipid-lowering agents. These
indicated that bococizumab was not likely to provide value to patients, physicians, or
shareholders. The decision was not based on a recommendation by the independent Data
Monitoring Committee to stop the program.

Inclusion Criteria:

- Must be on background lipid lowering treatment.

- Must be at high risk of a CV event.

- Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

- Planned coronary (PCI or CABG) or other arterial revascularization.

- New York Heart Association Class IV congestive heart failure or left ventricular
ejection fraction < 25% by cardiac imaging.

- Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
formula or with end state renal disease on dialysis.

- History of hemorrhagic stroke.

- Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
We found this trial at
512
sites
Investigational Product Shipment Address TO: Investigational Drug Services (IDS)
Houston, Texas 77030
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Integrated Medical Research, PC
148 E. Hersey St.
Ashland, Oregon 97520
541-488-9325
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Ashland, OR
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Upstate Pharmaceutical Research
30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
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East Coast Institute for Research
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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International Research Associates
8200 SW 117th Ave # 210
Miami, Florida 33183
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Aba Family Medicine
Ormond Beach, Florida 32174
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South Broward Research
Pembroke Pines, Florida 33027
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Intercoastal Medical Group
Sarasota, Florida 34232
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St. Joseph's Medical Associates
1805 N. California Street
Stockton, California 95204
209-939-3877
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Abington Hosptial
Abington, Pennsylvania 19001
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Radiant Research, Inc.
Akron, Ohio 44311
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Albany Medical College Division of Community Endocrinology
Albany, New York 12206
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Albuquerque Clinical Trials
Albuquerque, New Mexico
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Endeavor Medical Research
Alpena, Michigan 49707
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Clinical Research Associates of Central PA
Altoona, Pennsylvania 16602
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PharmaTex Research
Amarillo, Texas 79106
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Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California 92801
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Alaska Heart Institute
Anchorage, Alaska 99508
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St. Joseph Mercy Health System (Drug shipment Only)
Ann Arbor, Michigan 48106
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University of Michigan - Domino Farms
Ann Arbor, Michigan 48106
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Anne Arundel Medical Center
Annapolis, Maryland 21401
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MedStar Cardiology Associates
Annapolis, Maryland 21401
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Arlington Family Research Center
Arlington, Texas 76012
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Northwest Heart Clinical Research
Arlington Heights, Illinois 60005
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North Alabama Research Center
Athens, Alabama 35811
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Ernest Hendrix, MD, PC
Athens, Alabama 35611
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta Center for Medical Research
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Atlanta Diabetes Associates
Atlanta, Georgia 30309
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ACRC - Cardiology
Atlantis, Florida 33462
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Maine Research Associates
Auburn, Maine 04210
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Austin Heart, P.A.
Austin, Texas 78756
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Texas Diabetes & Endocrinology, PA
Austin, Texas 78731
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Instituto de Investigaciones Clinicas Bahia Blanca
Bahia Blanca, Buenos Aires
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Premier Valley Medical Group
Bakersfield, California 93309
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Overlea Personal Physicians
Baltimore, Maryland 21236
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Maryland Cardiovascular Specialists
Baltimore, Maryland 21229
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MedStar Chesapeake CardioVascular Associates
Baltimore, Maryland 21204
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MedStar Union Memorial Heart Specialists
Baltimore, Maryland 21218
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Shahid Saeed, MD, PC
Baltimore, Maryland 21237
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Acadia Clinical Research, LLC
Bangor, Maine 04401
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John V. Bernard, MD dba Wellness and Research Center
Belvidere, New Jersey 07823
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Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
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Westside Medical Associates of Los Angeles
Beverly Hills, California 90211
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QUEST Research Institute
Bingham Farms, Michigan 48025
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Birmingham Heart Clinic
Birmingham, Alabama 35235
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Central Alabama Research
Birmingham, Alabama 35209
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Kirklin Clinic
Birmingham, Alabama 35233
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University of Alabama at Birmingham (Drug Shipment)
Birmingham, Alabama 35294
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Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama 35211
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Elite Clinial Trials, LLLP
1443 Parkway Drive
Blackfoot, Idaho 83221
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Elite Clinical Trials (Additional Administrative Room / Exam Rooms)
Blackfoot, Idaho 83221
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Grace Research, LLC
Bossier City, Louisiana 71111
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Utah Cardiology, PC
Bountiful, Utah 84010
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Bridgeport Hospital
Bridgeport, Connecticut 06610
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Connecticut Clinical Research, LLC
Bridgeport, Connecticut 06606
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Advanced Heart Care, LLC
Bridgewater, New Jersey
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NY Total Medical Care
Brooklyn, New York 11215
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NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
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Sorin Medical, P.C.
Brooklyn, New York 11214
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Investigator's Research Group
Brownsburg, Indiana
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Southbay Pharma Research
Buena Park, California 90620
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Buffalo Heart Group LLP
Buffalo, New York 14215
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The Office of Daniel W. Gottlieb, MD, PS
Burien, Washington 98166
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Burke Internal Medicine And Research
Burke, Virginia 22015
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Clinical Research Institute of Northern Virginia
Burke, Virginia 22015
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St. Luke's Idaho Cardiology Associates
Caldwell, Idaho 83605
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Cranbrook Cardiology Research Associates
Cape Elizabeth, Maine 04107
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Pioneer Medical Group
Cerritos, California 90703
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Aztec Medical Research, Inc.
Channelview, Texas 77530
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Coastal Cardiology
Charleston, South Carolina
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Sensenbrenner Primary Care
Charlotte, North Carolina 28277
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Novant Health Heart and Vascular Institute
Charlotte, North Carolina 28204
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Novant Health Clinical Research
Charlotte, North Carolina 28204
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IHA Chelsea Family & Internal Medicine
Chelsea, Michigan 48118
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Lourdes Cardiology Services
Cherry Hill, New Jersey 08034
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Apex Medical Research, AMR, Inc
Chicago, Illinois 60616
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Clinical Research Advantage, Inc./Michigan Avenue Internists
Chicago, Illinois 60604
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Clinical Research Advantage,Inc./Medical and Procedural Specilaists of Illinois
Chicago, Illinois 60631
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Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio 45212
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Sterling Research Group
Cincinnati, Ohio 45219
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The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
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Mid-Cumberland Infectious Disease Consultants, PLC
Clarksville, Tennessee 37043
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NC Heart and Vascular
Clayton, North Carolina 27520
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Gulfcoast Endocrine and Diabetes Center
Clearwater, Florida 33756
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Morton Plant Mease Health Care, Inc. Cardiovascular Research
1200 Druid Road South
Clearwater, Florida 33756
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
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The Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44195
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Collierville Medical Specialists
Collierville, Tennessee 38017
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Colorado Springs Health Partners, Pc
Colorado Springs, Colorado 80922
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Lynn Institute of the Rockies
Colorado Springs, Colorado 80907
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Memorial Hospital - Univ. of Colorado Health
Colorado Springs, Colorado 80909
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Missouri Cardiovascular Specialists, LLP
Columbia, Missouri 65201
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Columbus Regional Research Institute
Columbus, Georgia 31904
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Radiant Research, Inc
Columbus, Ohio 43212
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Optimed Research, LTD
Columbus, Ohio 43235
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John Muir Physician Network Clinical Research Center
Concord, California 94520
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Rockdale Medical Research Associates
Conyers, Georgia 30094
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Team Medical Research
Coral Gables, Florida 33134
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