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

Last updated: October 30, 2013
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Thrombosis

Circulation Disorders

Lung Injury

Treatment

N/A

Clinical Study ID

NCT00633893
CV185-057
EUDRACT: 2007-004953-27
  • Ages > 18
  • All Genders

Study Summary

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women ≥ 18 years of age;

  • Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);

  • Anticoagulant treatment completed

  • No recurrence of Venous Thromboembolism (VTE)

Exclusion

Exclusion Criteria:

  • Subjects with indications for long-term treatment with a vitamin K antagonist

  • Active bleeding or high risk for serious bleeding

  • Short life expectancy

  • Uncontrolled high blood pressure

  • Impaired kidney or liver function

Study Design

Total Participants: 2711
Study Start date:
May 01, 2008
Estimated Completion Date:
August 31, 2012

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    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 1093 AAS
    Argentina

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    Ciudad De Buenos Aires, Buenos Aires C1034ACO
    Argentina

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    Coronel Suarez, Buenos Aires B7540GHD
    Argentina

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    La Plata, Buenos Aires 1900
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    Mar Del Plata, Buenos Aires 7600
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    San Martin, Buenos Aires B1650CSQ
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    Rosario, Santa Fe S2000CVB
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    Buenos Aires, C1431FWO
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    Cordoba, 5000
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    Corrientes, 3400
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    Garran, Australian Capital Territory 2605
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    Kogarah, New South Wales 2217
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    Lismore, New South Wales 2480
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    St Leonards, New South Wales 2065
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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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  • Fort Smith Lung Center

    Fort Smith, Arkansas 72901
    United States

    Site Not Available

  • Beaver Medical Group

    Banning, California 92220
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Carson, California 90746
    United States

    Site Not Available

  • Scripps Clinic/Scripps Health And Green Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Los Angeles, California 90015
    United States

    Site Not Available

  • Howard R. Sawyer, Md

    Mission Hills, California 91345
    United States

    Site Not Available

  • Mission Internal Medical Group

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Sutter Gould Medical Foundation

    Modesto, California 95355
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Monterey Park, California 91754
    United States

    Site Not Available

  • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Healthcare Partners

    Pasadena, California 91105
    United States

    Site Not Available

  • Indus Clinical Research Institute, Inc.

    Pomona, California 91767
    United States

    Site Not Available

  • Sharp Rees-Stealy Medical Group, Inc.

    San Deigo, California 92101
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    San Francisco, California 94118
    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

  • Progressive Clinical Research

    Vista, California 92083
    United States

    Site Not Available

  • Rocky Mountain Internal Medicine

    Aurora, Colorado 80012
    United States

    Site Not Available

  • New West Physicians

    Golden, Colorado 80401
    United States

    Site Not Available

  • The William W. Backus Hospital

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Alfieri Cardiology

    Newark, Delaware 19713
    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

  • Research Alliance, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • St. Francis Sleep Allergy & Lung Institute

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Berma Research Group

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Clinical Research Institute Of South Florida, Llc

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Healthworx

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Pds Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Hematology Oncology Associates

    Loxahatchee, Florida 33470
    United States

    Site Not Available

  • Local Institution

    Melbourne, Florida 32901
    United States

    Site Not Available

  • South Miami Heart Center

    Miami, Florida 33143
    United States

    Site Not Available

  • Physicians Regional Medical Group

    Naples, Florida 34119
    United States

    Site Not Available

  • Central Florida Pulmonary Group, P.A

    Orlando, Florida 32803
    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

  • Primary Care Of The Treasure Coast, Inc.

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Vascular Surgical Associates, Pc

    Austell, Georgia 30106
    United States

    Site Not Available

  • Atlanta Institute For Medical Research, Inc

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Chatham Hospitalists

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Boise Orthopedic Clinic

    Boise, Idaho 83706
    United States

    Site Not Available

  • Saltzer Medical Group

    Nampa, Idaho 83686
    United States

    Site Not Available

  • Infectious Disease Of Indiana Psc

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Office Of:Eugene C. Fletcher, Md

    New Albany, Indiana 47150
    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

  • Local Institution

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Owensboro Heart & Vascular

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Pen Bay Medical Center

    Rockport, Maine 04856
    United States

    Site Not Available

  • Anne Arundel Health System Research Institute, Inc.

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Burlington Medical Associates

    Billerica, Massachusetts 01821
    United States

    Site Not Available

  • Cape Cod Research Institute

    Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Mississippi Medical Research, Llc

    Picayune, Mississippi 39466
    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

  • Gateway Cardiology, P.C.

    St. Louis, Missouri 63128
    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

  • Kaleida Health System

    Buffalo, New York 14209
    United States

    Site Not Available

  • Goshen Medical Associates

    Goshen, New York 10924
    United States

    Site Not Available

  • Sjh Cardiology Associates

    Liverpool, New York 13088
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    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

  • Thomas L. Ortel, Md, Phd

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Valley Internal Medicine

    Fayetteville, North Carolina 28304
    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

  • Whiteville Medical Associates, P.A.

    Whiteville, North Carolina 28472
    United States

    Site Not Available

  • Wilmington Medical Research

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Akron General Medical Center

    Akron, Ohio 44307
    United States

    Site Not Available

  • Community Health Care, Inc.

    Canal Fulton, Ohio 44614
    United States

    Site Not Available

  • Valley Medical Research

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Huron Hospital

    Cleveland, Ohio 44112
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Remington Davis Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Jobst Vascular Center At The Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Cor Clinical Research, Llc

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Local Institution

    Portland, Oregon 97201
    United States

    Site Not Available

  • Vita Medical Associates P.C.

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Pma Medical Specialists

    Phoenixville, Pennsylvania 19460
    United States

    Site Not Available

  • Jefferson Hospital Medical Building

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Charleston Hematology Oncology Associates, Pa

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Greenville Hospital System

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Three Rivers Medical Associates, Pa

    Irmo, South Carolina 29063
    United States

    Site Not Available

  • Clinical Research Authority, Llc

    Murrells Inlet, South Carolina 29576
    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

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Amarillo Heart Clinical Research Institute Inc.

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Corsicana Medical Research

    Corsicana, Texas 75110
    United States

    Site Not Available

  • Ankur Doshi, Md

    Houston, Texas 77024
    United States

    Site Not Available

  • Northwest Heart Center

    Tomball, Texas 77375
    United States

    Site Not Available

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Site Not Available

  • University Of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University Of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara York Clinical Research

    Norfolk, Virginia 23510
    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

  • Medical Assoicates Inc.

    Menomonee Falls, Wisconsin 53051
    United States

    Site Not Available

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