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

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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 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
ICTR/Baylor College of Medicine
Houston, Texas 77030
1357
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Houston, TX
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Integrated Medical Research, PC
148 E. Hersey St.
Ashland, Oregon 97520
541-488-9325
616
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Ashland, OR
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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...
1777
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Birmingham, AL
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Seidman Clinical Trials
5258 Linton Blvd # 205
Delray Beach, Florida 33484
2307
mi
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Delray Beach, FL
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Upstate Pharmaceutical Research
30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
2021
mi
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Greenville, SC
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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...
1357
mi
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Houston, TX
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
2134
mi
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Jacksonville, FL
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East Coast Institute for Research
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
2134
mi
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Jacksonville, FL
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DCOL Center for Clinical Research
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
1345
mi
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Longview, TX
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International Research Associates
8200 SW 117th Ave # 210
Miami, Florida 33183
2313
mi
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Miami, FL
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Florida Hospital and Cardiovascular Institute
Orlando, Florida 32801
2184
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Orlando, FL
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Aba Family Medicine
Ormond Beach, Florida 32174
2183
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South Broward Research
Pembroke Pines, Florida 33027
2307
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Redpoint Research
11045 N. 19th Avenue
Phoenix, Arizona 85029
602-395-1200
341
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Phoenix, AZ
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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...
1183
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San Antonio, TX
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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...
1183
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San Antonio, TX
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Intercoastal Medical Group
Sarasota, Florida 34232
2150
mi
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Sarasota, FL
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St. Joseph's Medical Associates
1805 N. California Street
Stockton, California 95204
209-939-3877
325
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Stockton, CA
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Harbor UCLA Medical Center
1000 W Carson St
Torrance, California 90502
23
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Torrance, CA
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Abington Memorial Hospital (administrative only)
Abington, Pennsylvania 19001
2377
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Abington, PA
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Radiant Research, Inc.
Akron, Ohio 44311
2040
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Albany Medical College Division of Community Endocrinology
Albany, New York 12206
2438
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Albany, NY
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Albuquerque Clinical Trials
Albuquerque, New Mexico
649
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Albuquerque, NM
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Alexandria Cardiology Clinic
Alexandria, Louisiana 71301
1494
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Alexandria, LA
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Endeavor Medical Research
Alpena, Michigan 49707
1973
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Alpena, MI
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Clinical Research Associates of Central PA
Altoona, Pennsylvania 16602
2203
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PharmaTex Research
Amarillo, Texas 79106
922
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Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California 92801
16
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Alaska Heart Institute
Anchorage, Alaska 99508
2341
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St. Joseph Mercy Health System
Ann Arbor, Michigan 48106
1929
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University of Michigan - Domino Farms
Ann Arbor, Michigan 48106
1931
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Anne Arundel Medical Center
Annapolis, Maryland 21401
2309
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MedStar Cardiology Associates
Annapolis, Maryland 21401
2309
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Arlington Family Research Center
Arlington, Texas 76012
1205
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Arlington, TX
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Northwest Heart Clinical Research
Arlington Heights, Illinois 60005
1713
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Arlington Heights, IL
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North Alabama Research Center
Athens, Alabama 35811
1787
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Ernest Hendrix, MD, PC
Athens, Alabama 35611
1762
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Athens, AL
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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...
1922
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Atlanta, GA
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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...
1919
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Atlanta, GA
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Atlanta Diabetes Associates
Atlanta, Georgia 30309
1918
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Atlanta, GA
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ACRC - Cardiology
Atlantis, Florida 33462
2305
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Maine Research Associates
Auburn, Maine 04210
2615
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Austin Heart, P.A.
Austin, Texas 78756
1211
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Austin, TX
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Texas Diabetes & Endocrinology, PA
Austin, Texas 78731
1209
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Austin, TX
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Instituto de Investigaciones Clinicas Bahia Blanca
Bahia Blanca, Buenos Aires
6165
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Premier Valley Medical Group
Bakersfield, California 93309
106
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Overlea Personal Physicians
Baltimore, Maryland 21236
2301
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Baltimore, MD
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Maryland Cardiovascular Specialists
Baltimore, Maryland 21229
2297
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MedStar Chesapeake CardioVascular Associates
Baltimore, Maryland 21204
2301
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MedStar Union Memorial Heart Specialists
Baltimore, Maryland 21218
2301
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Shahid Saeed, MD, PC
Baltimore, Maryland 21237
2301
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Acadia Clinical Research, LLC
Bangor, Maine 04401
2685
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Bangor, ME
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SouthEast Texas Clinical Research Center
Beaumont, Texas 77702
1421
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Beaumont, TX
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Southeast Texas Cardiology Associates II, L.L.P.
Beaumont, Texas 77702
1421
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Beaumont, TX
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John V. Bernard, MD dba Wellness and Research Center
Belvidere, New Jersey 07823
2376
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Belvidere, NJ
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Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
22
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Westside Medical Associates of Los Angeles
Beverly Hills, California 90211
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Birmingham Heart Clinic
Birmingham, Alabama 35235
1792
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Central Alabama Research
Birmingham, Alabama 35209
1784
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Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama 35243
1790
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Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama 35211
1782
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Elite Clinial Trials
Blackfoot, Idaho 83221
699
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Blackfoot, ID
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Elite Clinial Trials, LLLP
1443 Parkway Drive
Blackfoot, Idaho 83221
699
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Blackfoot, ID
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Utah Cardiology, PC
Bountiful, Utah 84010
578
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Bountiful, UT
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Bridgeport Hospital
Bridgeport, Connecticut 06610
2473
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Bridgeport, CT
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Connecticut Clinical Research, LLC
Bridgeport, Connecticut 06606
2473
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Advanced Heart Care, LLC
Bridgewater, New Jersey
2402
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Bridgewater, NJ
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NY Total Medical Care
Brooklyn, New York 11215
2436
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Brooklyn, NY
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NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
2437
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Sorin Medical, P.C.
Brooklyn, New York 11214
2433
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Meridien Research
Brooksville, Florida
2126
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Investigator's Research Group
Brownsburg, Indiana
1780
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Southbay Pharma Research
Buena Park, California 90620
16
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Buffalo Heart Group LLP
Buffalo, New York 14215
2184
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Buffalo, NY
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The Office of Daniel W. Gottlieb, MD, PS
Burien, Washington 98166
951
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Burien, WA
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Burke Internal Medicine And Research
Burke, Virginia 22015
2269
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Burke, VA
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Clinical Research Institute of Northern Virginia
Burke, Virginia 22015
2268
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Burke, VA
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Kernodle Clinic, Department of the Private Diagnostic Clinic, PLLC
Burlington, North Carolina 27215
2171
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St. Luke's Idaho Cardiology Associates
Caldwell, Idaho 83605
666
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Caldwell, ID
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Med Center
Carmichael, California 95608
364
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Carmichael, CA
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Pioneer Medical Group
Cerritos, California 90703
15
mi
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Cerritos, CA
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Aztec Medical Research, Inc.
Channelview, Texas 77530
1372
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Channelview, TX
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Coastal Cardiolgy
Charleston, South Carolina 29407
2185
mi
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Charleston, SC
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Pmg Research Of Charlotte
Charlotte, North Carolina 28209
2101
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Charlotte, NC
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Sensenbrenner Primary Care
Charlotte, North Carolina 28277
2102
mi
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Charlotte, NC
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Novant Health Heart and Vascular Institute
Charlotte, North Carolina 28204
2102
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Charlotte, NC
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Novant Health Clinical Research
Charlotte, North Carolina 28204
2101
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Charlotte, NC
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IHA Chelsea Family & Internal Medicine
Chelsea, Michigan 48118
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Chelsea, MI
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Lourdes Cardiology Services
Cherry Hill, New Jersey 08034
2382
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Apex Medical Research, AMR, Inc
Chicago, Illinois 60616
1729
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Chicago, IL
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Clinical Research Advantage, Inc./Medical and Procedural Specialists of Illinois
Chicago, Illinois 60631
1721
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Chicago, IL
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Clinical Research Advantage, Inc./Michigan Avenue Internists
Chicago, Illinois 60604
1729
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Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio 45212
1882
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Sterling Research Group
Cincinnati, Ohio 45219
1879
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The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
1879
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Mid-Cumberland Infectious Disease Consultants, PLC
Clarksville, Tennessee 37043
1729
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NC Heart and Vascular
Clayton, North Carolina 27520
2230
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Gulf Coast Endocrine and Diabetes Center
Clearwater, Florida 33756
2117
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
2041
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Cleveland, OH
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The Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44195
2033
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Collierville Medical Specialists
Collierville, Tennessee 38017
1609
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