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:7/13/2018
Start Date:October 29, 2013
End Date:March 22, 2017

Use our guide to learn which trials are right for you!

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 occurrence 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 >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL
(2.6 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 >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 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
541
sites
Buynak Clinical Research, P.C.
55 University Drive
Valparaiso, Indiana 46383
?
mi
from
Valparaiso, IN
Click here to add this to my saved trials
Integrated Medical Research, PC
148 E. Hersey St.
Ashland, Oregon 97520
541-488-9325
?
mi
from
Ashland, OR
Click here to add this to my saved trials
University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Seidman Clinical Trials
5258 Linton Blvd # 205
Delray Beach, Florida 33484
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Upstate Pharmaceutical Research
30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
?
mi
from
Greenville, SC
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
East Coast Institute for Research
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
DCOL Center for Clinical Research
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
?
mi
from
Longview, TX
Click here to add this to my saved trials
International Research Associates
8200 SW 117th Ave # 210
Miami, Florida 33183
?
mi
from
Miami, FL
Click here to add this to my saved trials
Florida Hospital and Cardiovascular Institute
Orlando, Florida 32801
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Aba Family Medicine
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
South Broward Research
Pembroke Pines, Florida 33027
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Redpoint Research
11045 N. 19th Avenue
Phoenix, Arizona 85029
602-395-1200
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
University of Texas Health Science Center at San Antonio
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
University of Texas Health Science Center at San Antonio
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Intercoastal Medical Group
Sarasota, Florida 34232
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
St. Joseph's Medical Associates
1805 N. California Street
Stockton, California 95204
209-939-3877
?
mi
from
Stockton, CA
Click here to add this to my saved trials
Harbor UCLA Medical Center
1000 W Carson St
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Abington Memorial Hospital (administrative only)
Abington, Pennsylvania 19001
?
mi
from
Abington, PA
Click here to add this to my saved trials
Radiant Research, Inc.
Akron, Ohio 44311
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany Medical College Division of Community Endocrinology
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque Clinical Trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexandria Cardiology Clinic
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Endeavor Medical Research
Alpena, Michigan 49707
?
mi
from
Alpena, MI
Click here to add this to my saved trials
Clinical Research Associates of Central PA
Altoona, Pennsylvania 16602
?
mi
from
Altoona, PA
Click here to add this to my saved trials
PharmaTex Research
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Alaska Heart Institute
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
St. Joseph Mercy Health System
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
University of Michigan - Domino Farms
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Anne Arundel Medical Center
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
MedStar Cardiology Associates
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Arlington Family Research Center
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Northwest Heart Clinical Research
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
North Alabama Research Center
Athens, Alabama 35811
?
mi
from
Athens, AL
Click here to add this to my saved trials
Ernest Hendrix, MD, PC
Athens, Alabama 35611
?
mi
from
Athens, AL
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta Diabetes Associates
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
ACRC - Cardiology
Atlantis, Florida 33462
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Maine Research Associates
Auburn, Maine 04210
?
mi
from
Auburn, ME
Click here to add this to my saved trials
Austin Heart, P.A.
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
Texas Diabetes & Endocrinology, PA
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Instituto de Investigaciones Clinicas Bahia Blanca
Bahia Blanca, Buenos Aires
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
Premier Valley Medical Group
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Overlea Personal Physicians
Baltimore, Maryland 21236
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Maryland Cardiovascular Specialists
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
MedStar Chesapeake CardioVascular Associates
Baltimore, Maryland 21204
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
MedStar Union Memorial Heart Specialists
Baltimore, Maryland 21218
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Shahid Saeed, MD, PC
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Acadia Clinical Research, LLC
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
SouthEast Texas Clinical Research Center
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Southeast Texas Cardiology Associates II, L.L.P.
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
John V. Bernard, MD dba Wellness and Research Center
Belvidere, New Jersey 07823
?
mi
from
Belvidere, NJ
Click here to add this to my saved trials
Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Westside Medical Associates of Los Angeles
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham Heart Clinic
Birmingham, Alabama 35235
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Central Alabama Research
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama 35243
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama 35211
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Elite Clinial Trials
Blackfoot, Idaho 83221
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
Elite Clinial Trials, LLLP
1443 Parkway Drive
Blackfoot, Idaho 83221
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
Utah Cardiology, PC
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Bridgeport Hospital
Bridgeport, Connecticut 06610
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Connecticut Clinical Research, LLC
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Advanced Heart Care, LLC
Bridgewater, New Jersey
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
NY Total Medical Care
Brooklyn, New York 11215
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Sorin Medical, P.C.
Brooklyn, New York 11214
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Meridien Research
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Investigator's Research Group
Brownsburg, Indiana
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
Southbay Pharma Research
Buena Park, California 90620
?
mi
from
Buena Park, CA
Click here to add this to my saved trials
Buffalo Heart Group LLP
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
The Office of Daniel W. Gottlieb, MD, PS
Burien, Washington 98166
?
mi
from
Burien, WA
Click here to add this to my saved trials
Burke Internal Medicine And Research
Burke, Virginia 22015
?
mi
from
Burke, VA
Click here to add this to my saved trials
Clinical Research Institute of Northern Virginia
Burke, Virginia 22015
?
mi
from
Burke, VA
Click here to add this to my saved trials
Kernodle Clinic, Department of the Private Diagnostic Clinic, PLLC
Burlington, North Carolina 27215
?
mi
from
Burlington, NC
Click here to add this to my saved trials
St. Luke's Idaho Cardiology Associates
Caldwell, Idaho 83605
?
mi
from
Caldwell, ID
Click here to add this to my saved trials
Med Center
Carmichael, California 95608
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
Pioneer Medical Group
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Aztec Medical Research, Inc.
Channelview, Texas 77530
?
mi
from
Channelview, TX
Click here to add this to my saved trials
Coastal Cardiolgy
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Pmg Research Of Charlotte
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Sensenbrenner Primary Care
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Novant Health Heart and Vascular Institute
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Novant Health Clinical Research
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
IHA Chelsea Family & Internal Medicine
Chelsea, Michigan 48118
?
mi
from
Chelsea, MI
Click here to add this to my saved trials
Lourdes Cardiology Services
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
Apex Medical Research, AMR, Inc
Chicago, Illinois 60616
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clinical Research Advantage, Inc./Medical and Procedural Specialists of Illinois
Chicago, Illinois 60631
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clinical Research Advantage, Inc./Michigan Avenue Internists
Chicago, Illinois 60604
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio 45212
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Sterling Research Group
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Mid-Cumberland Infectious Disease Consultants, PLC
Clarksville, Tennessee 37043
?
mi
from
Clarksville, TN
Click here to add this to my saved trials
NC Heart and Vascular
Clayton, North Carolina 27520
?
mi
from
Clayton, NC
Click here to add this to my saved trials
Gulf Coast Endocrine and Diabetes Center
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Rapid Medical Research, Inc.
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
The Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Collierville Medical Specialists
Collierville, Tennessee 38017
?
mi
from
Collierville, TN
Click here to add this to my saved trials