Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00457002
First received: April 4, 2007
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.


Condition Intervention Phase
Venous Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Composite of venous thromboembolism (VTE) and VTE-related death [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes include all cause death, major bleeding, and clinically relevant non-major bleeding [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6524
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Drug: Apixaban

Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Other Name: BMS-562247
Active Comparator: Arm 2

While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)

Drug: Enoxaparin

Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days


  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • 40 years or older
  • hospitalized with congestive heart failure or acute respiratory failure
  • infection (without septic shock)
  • acute rheumatic disorder
  • inflammatory bowel disease

Exclusion Criteria:

  • patients with VTE
  • active bleeding or at high risk of bleeding
  • unable to take oral medication
  • with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457002

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham Hospital
Birmingham, Alabama, United States, 35294
Heart Center Research, Llc
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85013
Az Pulmonary Specialists Ltd
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Fort Smith Lung Center
Fort Smith, Arkansas, United States, 72901
United States, California
Scripps Clinic/Scripps Health And Green Hospital
La Jolla, California, United States, 92037
Va Long Beach Healthcare System
Long Beach, California, United States, 90822
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Dr. Felt Medical Office
Oakland, California, United States, 94609
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
Research Alliance, Inc.
Clearwater, Florida, United States, 33756
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32216
Pensacola Lung Group
Pensacola, Florida, United States, 32504
Indian River Med. Ctr.
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta Institute For Medical Research, Inc
Atlanta, Georgia, United States, 30030
Pulmonary & Critical Care Of Atlanta
Atlanta, Georgia, United States, 30342
United States, Idaho
Idaho Falls Infectious Diseases, Pllc
Idaho Falls, Idaho, United States, 83404
United States, Illinois
West Suburban Hospital
Oak Park, Illinois, United States, 60302
United States, Indiana
Infectious Disease Of Indiana Psc
Carmel, Indiana, United States, 46032
United States, Kansas
Cotton-O-Neil Clinical Research Center
Topeka, Kansas, United States, 66604
United States, Louisiana
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21205
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
United States, Michigan
Henry Ford Hospital, Transplant Institute
Detriot, Michigan, United States, 48202
United States, Missouri
University Of Missouri-Columbia
Columbia, Missouri, United States, 65212
United States, Montana
Mercury Street Medical Group, Pllc
Butte, Montana, United States, 59701
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Morristown Memorial Hospital
Mornstown, New Jersey, United States, 07962
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Mission Hospital, Inc
Asheville, North Carolina, United States, 28801
United States, Oklahoma
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
The Milton S Hershey Medical Center Of Penn. State Univ.
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Palmetto Nephrology Pa
Orangeburg, South Carolina, United States, 29118
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Health Presbyterian Dallas
Dallas, Texas, United States, 75231
Michael E. De Bakey Veteran Affairs Medical Center
Houston, Texas, United States, 77030
Sonterra Clinical Research
San Antonio, Texas, United States, 78205
Sonterra Clinical Research
San Antonio, Texas, United States, 78258
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
University Of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Mcguire Va Medical Center
Richmond, Virginia, United States, 23249
Argentina
Local Institution
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1280AEB
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Coronel Suarez, Buenos Aires, Argentina, B7540GHD
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Derqui-Pilar, Buenos Aires, Argentina, B1629ODT
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La Plata, Buenos Aires, Argentina, 1900
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Munro, Buenos Aires, Argentina, B1605DSX
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San Martin, Buenos Aires, Argentina, B1650CSQ
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Rosario, Santa Fe, Argentina, 2000
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Rosario, Santa Fe, Argentina, S2002KDS
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San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
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Buenos Aires, Argentina, C1181ACH
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Cordoba, Argentina, X5006IKK
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Cordoba, Argentina, 5000
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Corrientes, Argentina, 3400
Australia, New South Wales
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Concord, New South Wales, Australia, 2139
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Kippa Ring, Queensland, Australia, 4021
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Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
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Woodville, South Australia, Australia, 5011
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Parkville, Victoria, Australia, 3050
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Ringwood East, Victoria, Australia, 3135
Austria
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Graz, Austria, 8036
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Wien, Austria, 1090
Belgium
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Ottignies, Waals-Brabant, Belgium, 1340
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Antwerpen, Belgium, 2060
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Brasschaat, Belgium, 2930
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Bruxelles, Belgium, 1070
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Huy, Belgium, 4500
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Leuven, Belgium, 3000
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30150
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Curitiba, Parana, Brazil, 80010
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Curitiba, Parana, Brazil, 80810
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Porto Alegre, Rio Grande Do Sul, Brazil, 91430
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020
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Botucatu, Sao Paulo, Brazil, 18618
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Campinas, Sao Paulo, Brazil, 13059
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15091
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Sao Paulo, Brazil, 04012
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Sao Paulo, Brazil, 05403
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Sao Paulo, Brazil, 04020
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Sao Paulo, Brazil, 04025
Canada, Ontario
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Ajax, Ontario, Canada, L1S 7K8
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Hamilton, Ontario, Canada, L8N 4A6
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Hamilton, Ontario, Canada, L8N 3Z5
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Windsor, Ontario, Canada, N9A 1C9
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Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
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Granby, Quebec, Canada, J2G 1T7
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3T 1E2
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H1T 2M4
Chile
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Temuco, Araucania, Chile, - - - - -
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Santiago, Metropolitana, Chile, 7500922
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Santiago, Metropolitana, Chile, 8207257
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Rancagua, Valparaiso, Chile, -----
Colombia
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Bogota, Colombia, -----
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Bucaramanga, Colombia, -----
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Medellin, Colombia, -----
Czech Republic
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Brno, Czech Republic, 656 91
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Jindrichuv Hradec, Czech Republic, 377 38
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Kladno, Czech Republic, 272 59
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Kyjov, Czech Republic, 697 01
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Ostrava, Czech Republic, 728 80
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Prague 2, Czech Republic, 128 08
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Praha 1, Czech Republic, 110 00
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Praha 5, Czech Republic, 150 06
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Usti Nad Labem, Czech Republic, 401 13
Denmark
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Aalborg, Denmark, 9100
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Aarhus N, Denmark, 8200
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Arhus C, Denmark, 8000
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Frederiksberg, Denmark, 2000
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Glostrup, Denmark, 2600
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Hellerup, Denmark, 2900
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Herlev, Denmark, 2730
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Herning, Denmark, 7400
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Hvidovre, Denmark, 2650
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Odense, Denmark, 5000
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Randers No, Denmark, 8930
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Silkeborg, Denmark, 8600
France
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Bordeaux, France, 33075
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Brest, France, 29200
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Brest Cedex, France, 29609
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Dijon Cedex, France, 21079
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Grenoble Cedex 9, France, 38043
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Lille Cedex, France, 59020
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Nancy, France, 54035
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Nimes Cedex 9, France, 30029
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Paris Cedex 10, France, 75475
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Paris Cedex 15, France, 75908
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Saint Etienne Cedex 02, France, 42055
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Vernon, France, 27207
Germany
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Bonn, Germany, 53127
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Coburg, Germany, 96450
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Darmstadt, Germany, 64283
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Dresden, Germany, 01099
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Dresden, Germany, 01307
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Hannover, Germany, 30625
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Karlsbad, Germany, 76307
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Luebeck, Germany, 23538
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Mannheim, Germany, 68167
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Offenbach, Germany, 63069
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Witten, Germany, 58455
Hong Kong
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Shatin, N.T., Hong Kong, -----
Hungary
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Budapest, Hungary, 1135
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Debrecen, Hungary, 4032
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Dunaujvaros, Hungary, 2400
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Eger, Hungary, 3300
India
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Vishakapatnam, Andhra-Pradesh, India, 530002
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Hyderabad, Andra Pradesh, India, 500004
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Ahemdabad, Gujarat, India, 380054
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Bangalore, Karnataka, India, 560034
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Indore, Madhya Pardesh, India, 452018
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Pune, Maharashtra, India, 411004
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Pune, Maharashtra, India, 411001
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Pune, Maharastra, India, 411001
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Ludhiana, Punjab, India, 141001
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Coimbatore, Tamil Nadu, India, 641004
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Madurai, Tamil Nadu, India, 625107
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Chennai, Tamil-Nadu, India, 600096
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Noida, Uttar Pradesh, India, 201301
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Ahmedabad, India, 380054
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Bangalore, India, 560054
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Bangalore, India, 560017
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Hyderabad, India, 500033
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Mumbai, India, 400008
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New Delhi, India, 110025
Israel
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Afula, Israel, 18101
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Ashkelon, Israel, 78308
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Beer Sheva, Israel, 84105
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Haifa, Israel, 31096
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Petach Tikva, Israel, 49100
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Safed, Israel, 13110
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Tel Hashomer, Israel, 52621
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Tel-Aviv, Israel, 64239
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Zerifin, Israel, 70300
Italy
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Chieti Scalo, Italy, 66013
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Cremona, Italy, 26100
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Padua, Italy, 35128
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Piacenza, Italy, 29100
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Reggio Emilia, Italy, 42100
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Treviso, Italy, 31100
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Vicenza, Italy, 36100
Korea, Republic of
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Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
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Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 137-040
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Suwon, Korea, Republic of, 443721
Malaysia
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Kubang Kerian, Kelantan, Malaysia, 16150
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Batu Caves, Selangor, Malaysia, 68100
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Johor Bahru, Malaysia, 80100
Mexico
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Mexico, Distrito Federal, Mexico, 06726
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Mexico, Distrito Federal, Mexico, 07760
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Monterrey, Nuevo Leon, Mexico, 64460
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Xalapa, Veracruz, Mexico, 91020
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Merida, Yucatan, Mexico, 97129
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Queretaro, Mexico, 76178
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San Luis Potosi, Mexico, 78220
Netherlands
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Den Helder, Netherlands, 1782 GZ
Norway
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Kongsvinger, Norway, 2226
Peru
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La Victoria, Lima, Peru, LIMA 13
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Arequipa, Peru, AREQUIPA54
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Callao, Peru, CALLAO 2
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Lima, Peru, LIMA 1
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Lima, Peru, LIMA 11
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Lima, Peru, LIMA 31
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Lima, Peru, LIMA 1
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Lima, Peru, LIMA 01
Philippines
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Cagayan De Oro City, Misamis Oriental, Philippines, 9000
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Las Pinas, Philippines, 1742
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Quezon City, Philippines, 1110
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Quezon City, Philippines, 1100
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Quezon City, Philippines, 1102
Poland
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Bydgoszcz, Poland, 85-168
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Krakow, Poland, 31-202
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Lodz, Poland, 91-347
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Nowa Sol, Poland, 67-100
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Poznan, Poland, 61-833
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Skierniewice, Poland, 96-100
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Warszawa, Poland, 03-737
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Warszawa, Poland, 01-138
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Wejherowo, Poland, 84-200
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Zielona Gora, Poland, 65-046
Russian Federation
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Moscow, Russian Federation, 129336
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Moscow, Russian Federation, 119991
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Moscow, Russian Federation, 117593
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Moscow, Russian Federation, 117292
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Moscow, Russian Federation, 111539
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Moscow, Russian Federation, 121309
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Moscow, Russian Federation, 115280
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Moscow, Russian Federation, 127018
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Odintsovo, Russian Federation, 143000
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Podolsk, Russian Federation, 142100
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Ryazan, Russian Federation, 390005
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Saint Petersburg, Russian Federation, 199106
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Saint-Petersburg, Russian Federation, 198205
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Saratov, Russian Federation, 410002
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Saratov, Russian Federation, 410054
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St Petersburg, Russian Federation, 195067
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St. Petersburg, Russian Federation, 193312
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St.Petersburg, Russian Federation, 192242
Singapore
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Singapore, Singapore, 308433
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Singapore, Singapore, 529889
South Africa
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Bloemfontein, Free State, South Africa, 9301
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Johannesburg, Gauteng, South Africa, 2193
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Pretoria, Gauteng, South Africa, 0044
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Amanzimtoti, Kwa Zulu Natal, South Africa, 4120
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Bellville, Western Cape, South Africa, 7530
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Groenkloof, South Africa, 0181
Spain
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Torrevieja, Alicante, Spain, 03186
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Alcorcon(Madrid), Spain, 28922
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Barcelona, Spain, 08036
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Barcelona, Spain, 08003
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Madrid, Spain, 28007
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Madrid, Spain, 28046
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Madrid, Spain, 28041
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Madrid, Spain, 28006
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Madrid, Spain, 28034
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Sevilla, Spain, 41013
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Tarragona, Spain, 43007
Sweden
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Goteborg, Sweden, 413 45
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Lund, Sweden, 221 85
Taiwan
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Yung-Kang City, Tainan, Taiwan, 710
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Taichung, Taiwan, 402
Turkey
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Istanbul, Capa, Turkey, 34390
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Ankara, Dikimevi, Turkey, 06100
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Istanbul, Turkey, 34390
Ukraine
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Donetsk, Ukraine, 83003
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Kharkiv, Ukraine, 61018
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Kharkiv, Ukraine, 61176
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Kharkov, Ukraine, 61039
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Kyiv, Ukraine, 03115
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Kyiv, Ukraine, 04050
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Kyiv, Ukraine, 02091
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Kyiv, Ukraine, 03151
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Kyiv, Ukraine, 04201
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Kyiv, Ukraine, 03680
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Kyiv, Ukraine, 01133
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Lutsk, Ukraine, 43024
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Lviv, Ukraine, 79010
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Uzhgorod, Ukraine, 88000
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Vinnitsa, Ukraine, 21029
United Kingdom
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London, Greater London, United Kingdom, SW3 6LR
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London, Greater London, United Kingdom, SE5 9RS
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Uxbridge, Middlesex, United Kingdom, UB8 3NN
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Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
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Dudley, West Midlands, United Kingdom, DY1 2HQ
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Hull, Yorkshire, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00457002     History of Changes
Other Study ID Numbers: CV185-036
Study First Received: April 4, 2007
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014