Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Last updated: April 17, 2014
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Lung Injury

Chest Pain

Treatment

warfarin

Placebo for enoxaparin

Enoxaparin

Clinical Study ID

NCT00643201
CV185-056
EUDRACT: 2007-007867-25
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women ≥ 18 years of age

  • Clinical diagnosis of DVT or PE

Exclusion

Exclusion Criteria:

  • Contraindications for enoxaparin or warfarin

  • Active bleeding or high risk for serious bleeding

  • Short life expectancy

  • Uncontrolled high blood pressure

  • Significantly impaired kidney or liver function

Study Design

Total Participants: 5614
Treatment Group(s): 6
Primary Treatment: warfarin
Phase: 3
Study Start date:
July 01, 2008
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Local Institution

    Capital Federal, Buenos Aires C1426ANZ
    Argentina

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    Ciudad Auto. De Buenos Aires, Buenos Aires 1180
    Argentina

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    Ciudad Autonoma De Buenos Aire, Buenos Aires C1180AAX
    Argentina

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    La Plata, Buenos Aires B1902COI
    Argentina

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    San Martin, Buenos Aires 1650
    Argentina

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    Rosario, Santa Fe 2000
    Argentina

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    Buenos Aires, C1280AEB
    Argentina

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    Cordoba, 5000
    Argentina

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    Corrientes, 3400
    Argentina

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    Garran, Australian Capital Territory 2605
    Australia

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    Concord, New South Wales 2139
    Australia

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    Kogarah, New South Wales 2217
    Australia

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    Lismore, New South Wales 2480
    Australia

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    Randwick, New South Wales 2031
    Australia

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    Herston, Queensland 4029
    Australia

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    Kippa Ring, Queensland 4021
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    Woolloongabba, Queensland 4102
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    Adelaide, South Australia 5000
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    Bedford Park, South Australia 5042
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    Hobart, Tasmania 7000
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    Launceston, Tasmania 7250
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    Box Hill, Victoria 3128
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    Clayton, Victoria 3168
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    Heidelberg, Victoria 3084
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    Parkville, Victoria 3050
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    Richmond, Victoria 3121
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    Ringwood East, Victoria 3135
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    Windsor, Victoria 3181
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    Perth, Western Australia 6001
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    Graz, 8036
    Austria

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    Innsbruck, 6020
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    Vienna, 1100
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    Wien, 1090
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    Salvador, Bahia 40144 900
    Brazil

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    Brasilia, Distrito Federal 70325
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    Belo Horizonte, Minas Gerais 30150
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    Belo Horizonte - Mg, Minas Gerais 30150
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    Curitiba, Parana 81520
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    Rio Janeiro, Rio De Janeiro 22280
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    Port Alegre, Rio Grande Do Sul 90020
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    Porto Alegre, Rio Grande Do Sul 90035
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    Sao Bernardo do Campo, SP 09715
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    Botucatu, Sao Paulo 18618
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    Campinas, Sao Paulo 13083
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    Liberdade, Sao Paulo 01509
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    Santo Andre, Sao Paulo 09060 B7U
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    Sao Jose Do Rio Preto, Sao Paulo 15090
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    Rio De Janeiro, 20551
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    Granby, Quebec J2G 1T7
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    Greenfield Park, Quebec J4V 2H1
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    Montreal, Quebec H1T 2M4
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    St Foy, Quebec G1V 4G5
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    St. Jerome, Quebec J7Z 5T3
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    Ostrava Vitkovice, 703 84
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    Praha 1, 118 33
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    Usti Nad Labem, 401 13
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    Usti Nad Orlici, 562 18
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    Arhus C, 8000
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    Frederiksberg, 2000
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    Cholet, 49300
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    Clamart, 92141
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    Clermont-Ferrand Cedex 01, 63003
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    Lille, 59000
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    Lyon Cedex 03, 69437
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    Paris, 75004
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    Pierre Benite, 69495
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    Saint-Priest En Jarez, 42270
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    Toulouse cedex 9, 31059
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    Tours Cedex 9, 37044
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    Miskolc, 3501
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    Mosonmagyarovar, 9200
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    Szekesfehervar, 8000
    Hungary

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    Hyderabad, Andhra Pradesh 500 082
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    Ahmedabad, Gujarat 380006
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    Gurgaon, Haryana 122001
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    Bengaluru, Karnataka 560017
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    Manipal, Karnataka 576104
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    Mumbai, Maharashtra 400 022
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    Pune, Maharashtra 411001
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    Mohali, Punjab 160062
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    Chennai, Tamil Nadu 600 006
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    Tiberias, Lower Galillee 15208
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    Petach-Tikwa, 49100
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    Passirana Di Rho, 20017
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    Perugia, 06132
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    Piacenza, 29100
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    Guadalajara, Jalisco 44280
    Mexico

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    Zapopan, Jalisco 45170
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    Monterrey, Nuevo Leon 64718
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    Puerto Rico

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    Ryazan, 390026
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    Saint Petersburg, 197022
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    Saint-Petersburg, 196247
    Russian Federation

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    Samara, 443099
    Russian Federation

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    Saratov, 410012
    Russian Federation

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    St Petersburg, 194044
    Russian Federation

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    Yaroslavl, 150062
    Russian Federation

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    Singapore, 529889
    Singapore

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    Bioemfontein, Free State 9301
    South Africa

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    Centurion, Gauteng 0157
    South Africa

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    Morningside, Gauteng 2057
    South Africa

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    Parktown, Gauteng 2193
    South Africa

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    Pretoria, Gauteng 0084
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    Durban, Kwa Zulu Natal 4001
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    Pietermaritzburg, Kwa Zulu Natal 3201
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    Bellville, Western Cape 7530
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    George, Western Cape 6529
    South Africa

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    Somerset West, Western Cape 7130
    South Africa

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    Worcester, Western Cape 6850
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    Orihuela, Alicante 03314
    Spain

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    Torrevieja, Alicante 03186
    Spain

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    Pozuelo De Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Local Institution

    San Sebastian De Los Reyes, Madrid 28702
    Spain

    Site Not Available

  • Local Institution

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution

    Getafe, 28905
    Spain

    Site Not Available

  • Local Institution

    Girona, 17007
    Spain

    Site Not Available

  • Local Institution

    L'Hospitalet De Llobregat, 08907
    Spain

    Site Not Available

  • Local Institution

    Leon, 24008
    Spain

    Site Not Available

  • Local Institution

    Madrid, 28007
    Spain

    Site Not Available

  • Local Institution

    Malaga, 29010
    Spain

    Site Not Available

  • Local Institution

    Mourente, 36071
    Spain

    Site Not Available

  • Local Institution

    Pamplona, 31008
    Spain

    Site Not Available

  • Local Institution

    Salamanca, 37007
    Spain

    Site Not Available

  • Local Institution

    Sant Boi De Llobregat, 08830
    Spain

    Site Not Available

  • Local Institution

    Tarragona, 43007
    Spain

    Site Not Available

  • Local Institution

    Ankara, 06100
    Turkey

    Site Not Available

  • Local Institution

    Istanbul, 34662
    Turkey

    Site Not Available

  • Local Institution

    Kayseri, 38039
    Turkey

    Site Not Available

  • Local Institution

    Chernihiv, 14034
    Ukraine

    Site Not Available

  • Local Institution

    Dnipropetrovsk, 49000
    Ukraine

    Site Not Available

  • Local Institution

    Donetsk, 83045
    Ukraine

    Site Not Available

  • Local Institution

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • Local Institution

    Kharkiv, 61018
    Ukraine

    Site Not Available

  • Local Institution

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Local Institution

    Lviv, 79010
    Ukraine

    Site Not Available

  • Local Institution

    Odesa, 65117
    Ukraine

    Site Not Available

  • Local Institution

    Ternopil, 46000
    Ukraine

    Site Not Available

  • Local Institution

    Vinnytsia, 21018
    Ukraine

    Site Not Available

  • Local Institution

    Zaporizhzhia, 69035
    Ukraine

    Site Not Available

  • Local Institution

    Livingston, West Lothian EH54 7BH
    United Kingdom

    Site Not Available

  • Alabama Clinical Therapeutics, Llc

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Horizon Research Group, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Local Institution

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Fort Smith Lung Center

    Fort Smith, Arkansas 72901
    United States

    Site Not Available

  • University Of Arkansas For Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Beaver Medical Group

    Banning, California 92220
    United States

    Site Not Available

  • University Of California San Francisco-Fresno

    Fresno, California 93701
    United States

    Site Not Available

  • Sutter Gould Medical Foundation

    Modesto, California 95355
    United States

    Site Not Available

  • University Of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Local Institution

    San Deigo, California 92101
    United States

    Site Not Available

  • Chest Medicine & Critical Care Medical Gr. Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Harbor Ucla Medical Center

    Torrance, California 90509
    United States

    Site Not Available

  • New West Physicians

    Golden, Colorado 80401
    United States

    Site Not Available

  • Drogue Medical, Llc

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • George Washington University Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Bay Pines Va Healthcare Systems

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • Daniel G. Lorch, Jr, Md, Cpi

    Brandon, Florida 33511
    United States

    Site Not Available

  • Research Alliance, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Clinical Research Institute Of South Florida, Llc

    Hialeah, Florida 33013
    United States

    Site Not Available

  • River City Clinical Research

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Local Institution

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Southeastern Clinical Research Consultants

    Orlando, Florida 32804
    United States

    Site Not Available

  • Richard A. Mclean M.D., P.A.

    Plantation, Florida 33317
    United States

    Site Not Available

  • Pasadena Center For Medical Research

    St. Petersburg, Florida 33707
    United States

    Site Not Available

  • Tampa Clinical Research

    Tampa, Florida 33624
    United States

    Site Not Available

  • Office Of Michele S. Maholtz Md

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Atlanta Pulmonary Group

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Atlanta Institute For Medical Research, Inc

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Chatham Hospitalists

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Gateway Cardiology. P.C

    Jerseyville, Illinois 62052
    United States

    Site Not Available

  • West Suburban Medical Center

    Oak Park, Illinois 60302
    United States

    Site Not Available

  • Infectious Disease Of Indiana Psc

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Heartland Vascular Medicine And Surgery

    Windsor Heights, Iowa 50324
    United States

    Site Not Available

  • Kentucky Lung Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Univ. Of Kentucky Dept. Of Surgery

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Research Integrity, Llc

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Pen Bay Medical Center

    Rockport, Maine 04856
    United States

    Site Not Available

  • Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Medstar Research Health Institute

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • R Adams Cowley Shock Trauma Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hurley Medical Center

    Flint, Michigan 48503
    United States

    Site Not Available

  • Mississippi Medical Research, Llc

    Picayune, Mississippi 39466
    United States

    Site Not Available

  • University Of Missouri-Columbia

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Veterans Affairs Medical Center

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Washington University School Of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • St. John'S Mercy Medical Center

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Mercury Street Medical Group, Pllc

    Butte, Montana 59701
    United States

    Site Not Available

  • Great Falls Clinic, Llp

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Internal Medical Associates Of Grand Island, P.C

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Morristown Memorial Hospital

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Pulmonary & Critical Care Services, Pc

    Albany, New York 12205
    United States

    Site Not Available

  • Kaleida Health System

    Buffalo, New York 14209
    United States

    Site Not Available

  • Local Institution

    Goshen, New York 10924
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • St. Luke'S Roosevelt Hospital Center

    New York, New York 10019
    United States

    Site Not Available

  • Richmond University Medical Center

    Staten Island, New York 10310
    United States

    Site Not Available

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, North Carolina 32127
    United States

    Site Not Available

  • Rex Healthcare

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Piedmont Healthcare/Research

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Wilmington Medical Research

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Clinical Trials Of America, Inc.

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Altru Health System Clinic

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Huron Hospital

    Cleveland, Ohio 44112
    United States

    Site Not Available

  • Remington Davis Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Local Institution

    Youngstown, Ohio 44501
    United States

    Site Not Available

  • Oregon Health Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Vita Medical Associates P.C.

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Local Institution

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Greenville Hospital System

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Palmetto Clinical Research

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Holston Medical Group

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Kore Cv Research

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Pmg Research Of Knoxville

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • Integrity Oncology, Pllc

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Southwest Pulmonary Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Primecare Medical Group

    Houston, Texas 77024
    United States

    Site Not Available

  • Cancer Care Centers Of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University Of Utah Medical Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Lake Washington Vascular, Pllc

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Franciscan Research Center

    Tacoma, Washington 98405
    United States

    Site Not Available

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