Trial record 1 of 1 for:    VTE 11-019
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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Portola Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01583218
First received: April 16, 2012
Last updated: May 7, 2014
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.


Condition Intervention Phase
Venous Thromboembolism (VTE)
Drug: Betrixaban
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: (Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 6850
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Betrixaban Drug: Betrixaban

Betrixaban 80 mg PO QD for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days

Active Comparator: Enoxaparin Drug: Enoxaparin

Enoxaparin 40 mg SC QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 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
  • anticipated to be severely immobilized for at least 24 hours after randomization
  • hospitalized with one of the following

    • congestive heart failure
    • acute respiratory failure,
    • acute infection without septic shock,
    • acute rheumatic disorders
    • acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

  • a condition requiring prolonged anticoagulation or anti-platelets
  • active bleeding or at high risk of bleeding
  • contraindication to anticoagulant therapy
  • general conditions in which subjects are not suitable to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583218

Contacts
Contact: APEX Study Clinical Trial Contact 855-256-7070 ApexClinicalStudy@Portola.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Recruiting
Bakersfield, California, United States, 93308
Recruiting
Fresno, California, United States, 93701
Recruiting
La Mesa, California, United States, 91942
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90073
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Modesto, California, United States, 95350
Recruiting
San Diego, California, United States, 92120
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Stanford, California, United States, 94305
Recruiting
Torrance, California, United States, 90509
United States, Colorado
Withdrawn
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Recruiting
Bay Pines, Florida, United States, 33744
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Clearwater, Florida, United States, 33756
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33143
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Pensacola, Florida, United States, 32504
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Sarasota, Florida, United States, 34232
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Vero Beach, Florida, United States, 32960
United States, Georgia
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30030
United States, Illinois
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Oak Park, Illinois, United States, 60302
United States, Indiana
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Carmel, Indiana, United States, 46032
United States, Iowa
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Windsor Heights, Iowa, United States, 50324
United States, Kansas
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Topeka, Kansas, United States, 66604
United States, Kentucky
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Hazard, Kentucky, United States, 41701
United States, Maryland
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Annapolis, Maryland, United States, 21401
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Baltimore, Maryland, United States, 21287
United States, Michigan
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Detroit, Michigan, United States, 48202
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Grand Blanc, Michigan, United States, 48439
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Royal Oak, Michigan, United States, 48073
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Troy, Michigan, United States, 48085
United States, Minnesota
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Duluth, Minnesota, United States, 55805
United States, Mississippi
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Picayune, Mississippi, United States, 39466
United States, Missouri
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Kansas, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63110
Withdrawn
St. Louis, Missouri, United States, 63141
United States, Montana
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Butte, Montana, United States, 59701
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Las Vegas, Nevada, United States, 89109
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Reno, Nevada, United States, 89502
United States, New Jersey
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Atlantic City, New Jersey, United States, 08401
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Pomona, New Jersey, United States, 08240
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Somerville, New Jersey, United States, 08876
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Summit, New Jersey, United States, 07901
United States, New York
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Buffalo, New York, United States, 14209
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Manhasset, New York, United States, 11030
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Staten Island, New York, United States, 10305
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Valhalla, New York, United States, 10595
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cincinnati, Ohio, United States, 45267
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Cleveland, Ohio, United States, 44106-5072
United States, Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
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Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
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Orangeburg, South Carolina, United States, 29118
United States, Texas
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Austin, Texas, United States, 78705
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Austin, Texas, United States, 78752
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Bellaire, Texas, United States, 77401
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Corsicana, Texas, United States, 75110
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Dallas, Texas, United States, 75216
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Houston, Texas, United States, 77030
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McAllen, Texas, United States, 78501
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Mission, Texas, United States, 78572
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78205
United States, Vermont
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Colchester, Vermont, United States, 05401
United States, Virginia
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Richmond, Virginia, United States, 23249
United States, Washington
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Everett, Washington, United States, 98201
United States, West Virginia
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Huntington, West Virginia, United States, 25701
Argentina
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Buenos Aires, Argentina, 1280
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Ciudad Autónoma de Buenos Aires, Argentina, C1181ACH
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Cordoba, Argentina, 5000
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Coronel Suarez, Buenos Aires, Argentina, B7540DOL
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Corrientes, Argentina, W3400AMZ
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Córdoba, Argentina, 5000
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El Talar, Argentina, 1618
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Rosario, Santa Fe, Argentina, S2000DSV
Recruiting
San Miguel de Tucumán, Argentina, T4000JCU
Australia, Queensland
Recruiting
Redcliffe, Queensland, Australia, 4020
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Australia
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Milton, Australia, Qld 4064
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Parkville, Australia, Vic 3050
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Randwick, Australia
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Richmond, Australia, Vic 3121
Austria
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Feldkirch, Austria, 6800
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Gratwein, Austria, 8112
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Graz, Austria, 8036
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Hartberg, Austria, 8230
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Linz, Austria, 4020
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Wien, Austria, 1100
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Wien, Austria, 1160
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Zams, Austria, 6511
Belgium
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Bruxelles, Belgium, 1070
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Huy, Belgium, 4500
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Leper, Belgium, 8900
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Leuven, Belgium, 3000
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Yvoir, Belgium, 5530
Brazil
Recruiting
Belo Horizonte - MG, Brazil, 30150-221
Recruiting
Botucatu, Brazil, 18618-970
Not yet recruiting
Brasilia, Brazil, 70710
Recruiting
Campinas, Brazil, 13083-970
Recruiting
Campinas, Sao Paulo, Brazil, 13059-740
Recruiting
Curitiba - PR, Brazil, 80030-001
Not yet recruiting
Porto Alegre, Brazil, 90620-001
Recruiting
Porto Alegre, Brazil, 90880-480
Not yet recruiting
Salvador, Brazil, 41810-011
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Sao Paulo, Brazil, 04012-909
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São José do Rio Preto- SP, Brazil, 15090-000
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São Paulo, Brazil, 01308-050
Recruiting
SãO Paulo, Brazil, 01323-903
Bulgaria
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Gabrovo, Bulgaria, 5300
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Pleven, Bulgaria, 5800
Not yet recruiting
Pleven, Bulgaria, 5800
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Sandanski, Bulgaria, 2800
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Sliven, Bulgaria, 8800
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Sofia, Bulgaria, 1784
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Sofia, Bulgaria, 1202
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1407
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Yambol, Bulgaria, 8600
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 4A6
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Ottawa, Ontario, Canada, K1H 8L6
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Thunder Bay, Ontario, Canada, P7B 6R4
Canada
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Ontario, Canada, N8X 5A6
Chile
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La Serena, Chile, 170000
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Osorno, Chile
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Santiago, Chile
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Santiago, Chile, 7650568
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Temuco, Chile, 4781173
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Viña del Mar, Chile, 2570017
Croatia
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Krapinske Toplice, Croatia, 49217
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Pula, Croatia, 52100
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Rijeka, Croatia, 51000
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Zadar, Croatia, 23000
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Zagreb, Croatia, 10000
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Zagreb, Croatia, 1000
Czech Republic
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Chrudim, Czech Republic, 537 27
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Kladno, Czech Republic, 272 01
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Kyjov, Czech Republic, 697 33
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Liberec, Czech Republic, 460 63
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Litomysl, Czech Republic, 570 14
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Olomouc, Czech Republic, 771 11
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Ostrava, Czech Republic, 703 84
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Plzen - Bory, Czech Republic, 305 99
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Praha 1, Czech Republic, 118 00
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Praha 1, Czech Republic, 110 00
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Praha 10, Czech Republic, 100 34
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Praha 5, Czech Republic, 150 06
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Slany, Czech Republic, 274 01
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Strakonice, Czech Republic, 386 29
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Usti nad Labem, Czech Republic, 401 13
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Zlin, Czech Republic, 762 75
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Znojmo, Czech Republic, 669 02
Denmark
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Frederiksberg, Denmark, DK-2000
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Haderslev, Denmark, DK-6100
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Hellerup, Denmark, DK-2900
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Hillerod, Denmark, DK-3400
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Hvidovre, Denmark, DK-2650
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Kobenhavn NV, Denmark, DK-2400
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Silkeborg, Denmark, DK-8600
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Slagelse, Denmark, DK-4200
Estonia
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Tallinn, Estonia, EE-13419
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Tallinn, Estonia, EE-10138
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Tartu, Estonia, EE-51014
Finland
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Helsinki, Finland, FI-00290
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Jyväskylä, Finland, FI-40620
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Kouvola, Finland, FI-45750
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Mikkeli, Finland, FI-50100
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Pori, Finland, FI-28500
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Turku, Finland, FI-20520
France
Recruiting
Angers, France, 49100
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Arras, France, 62022
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Avignon, France, 84918
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Bois-Guillaume, France, 76230
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Bordeaux, France, 33075
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Brest, France, 29200
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Brest, France, 29609
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Castelnau-le-Lez, France, 34170
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Clermont-Ferrand, France, 63003
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Colombes, France, 92700
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Dijon, France, 21079
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La Tronche, France, 38043
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Le Mans, France, 72037
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Lille, France, 59020
Recruiting
Limoges, France, 87 042
Withdrawn
Lyon, France, 69003
Recruiting
Montpellier, France, 34295
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Nantes, France, 44093
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Nimes, France, 30029 cedex 9
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Paris, France, 75908
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Paris, France, 75010
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Paris, France, 75004
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Pierre Benite, France, 69495
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Quimper, France, 29107
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Rennes, France, 35203
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Saint-Priest en Jarrez, France, 42055
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Tourcoing, France, 59200
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Valenciennes, France, 59300
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Vernon, France, 27207
Germany
Recruiting
Berlin, Germany, 10787
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Bonn, Germany, 53115
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Dresden, Germany, 01067
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Dresden, Germany, 01307
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Essen, Germany, 45147
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Hamburg, Germany, 22559
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Heidelberg, Germany, 69120
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Karlbad, Germany, 76307
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Magdeburg, Germany, 39120
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Mainz, Germany, 55131
Recruiting
Möchengladbach, Germany, 41063
Recruiting
Neuss, Germany, 41464
Recruiting
Oberhausen, Germany, 46045
Recruiting
Paderborn, Germany, 33098
Not yet recruiting
Rüsselsheim, Germany, 65428
Recruiting
Troisdorf, Germany
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Weiden, Germany, 92637
Recruiting
Wesel, Germany, 46483
Recruiting
Wiesbaden, Germany, 65199
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Witten, Germany, 58455
Hungary
Recruiting
Baja, Hungary, 6500
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Balassagyarmat, Hungary, 2660
Recruiting
Balatonfüred, Hungary, 8231
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Berettyóújfalu, Hungary, 4100
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Budapest, Hungary, 1125
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Budapest, Hungary, 1122
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Budapest, Hungary, 1097
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Budapest, Hungary, 1145
Recruiting
Budapest,, Hungary, 1134
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Cegléd, Hungary, 2700
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Debrecen, Hungary, 4032
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Debrecen, Hungary, H-4012
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Eger, Hungary, 3300
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Gyula, Hungary, 5700
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Hódmezövásárhely, Hungary, 6800
Recruiting
Kistarcsa, Hungary, 2143
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Mohács, Hungary, 7700
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Nagykanizsa, Hungary, 8800
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Szekszárd, Hungary, 7100
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Szolnok, Hungary, 5000
Recruiting
Veszprém, Hungary, 8200
Recruiting
Zalaegerszeg, Hungary, 8900
Israel
Recruiting
Afula, Israel, 18101
Recruiting
Ashkelon, Israel, 78278
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Haifa, Israel, 31096
Recruiting
Haifa, Israel, 31048
Withdrawn
Holon, Israel, 58100
Recruiting
Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
Withdrawn
Nahariya, Israel, 22100
Recruiting
Petach Tikva, Israel, 49100
Recruiting
Safed, Israel, 13100
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Tel Aviv, Israel, 64239
Recruiting
Zerifin, Israel, 70300
Italy
Recruiting
Castelfranco Veneto, Treviso, Italy, 31033
Recruiting
Bollate, Italy, 20021
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Frenze, Italy, 50134
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Genova, Italy, 16128
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Milano, Italy, 20132
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Milano, Italy, 20085
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Parma, Italy, 43100
Recruiting
Pavia, Italy, 27100
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Piacenza, Italy, 29121
Not yet recruiting
Reggio Emilia, Italy, 42100
Recruiting
Roma, Italy, 00168
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Varese, Italy, 21100
Recruiting
Vittorio Veneto TV, Italy, 31029
Latvia
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Daugavpils, Latvia, LV-5417
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Liepaja, Latvia, LV-3414
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Riga, Latvia, LV-1002
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Riga, Latvia, LV-1038
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Valmiera, Latvia, LV-4201
Lithuania
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Alytus, Lithuania, LT-62114
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Kaunas, Lithuania, LT-44320
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Kaunas, Lithuania, LT-47144
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Kaunas, Lithuania, LT-45130
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Klaipeda, Lithuania, LT-92231
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Klaipeda, Lithuania, LT-92288
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Siauliai, Lithuania, LT-76231
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Utena, Lithuania, 28151
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Vilnius, Lithuania, LT-10207
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Vilnius, Lithuania, LT-04130
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Vilnius, Lithuania, LT-08411
Montserrat
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Picayune, MS, Montserrat, 39466
Peru
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Arequipa, Peru, 05154
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Callao, Peru, CALLAO 2
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Lima, Peru, 01
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Lima, Peru, LIMA 13
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Lima, Peru, Lima 11
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Lima, Peru, 18
Poland
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Bialystok, Poland, 15-276
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Bydgoszcz, Poland, 85-681
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Czeladz, Poland, 41-250
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Gdansk, Poland, 80-803
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Krakow, Poland, 31-121
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Krakow, Poland, 31-913
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Skierniewice, Poland, 96-100
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Tarnobrzeg, Poland, 39-400
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Warszawa, Poland, 02-097
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Warszawa, Poland, 01-138
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Wloclawek, Poland, 87-800
Romania
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Baia, Romania, 430031
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Bucharest, Romania, 022328
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Bucharest, Romania, 020475
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Bucharest, Romania, 021659
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Bucharest, Romania, 041915
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Cluj-Napoca, Romania, 40001
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Craiova, Romania, 200642
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Iasi, Romania, 700620
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Targu Mures, Romania, 540136
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Timisoara, Romania, 300736
Russian Federation
Recruiting
Arkhangelsk, Russian Federation, 163045
Recruiting
Barnaul, Russian Federation, 656024
Not yet recruiting
Barnaul, Russian Federation, 656045
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Belgorod, Russian Federation, 308007
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Chelyabinsk, Russian Federation, 454048
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Chelyabinsk, Russian Federation, 454091
Recruiting
Ekaterinburg, Russian Federation, 620219
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Ekaterinburg, Russian Federation, 620039
Active, not recruiting
Irkutsk, Russian Federation, 664049
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Kaluga, Russian Federation, 428007
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Kazan, Russian Federation, 420043
Active, not recruiting
Kazan, Russian Federation, 420012
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Kemerovo, Russian Federation, 650002
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Kirov, Russian Federation, 610014
Active, not recruiting
Krasnodar, Russian Federation, 350086
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Lubertsy, Russian Federation, 140006
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Moscow, Russian Federation, 111539
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Moscow, Russian Federation, 119992
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Moscow, Russian Federation, 117292
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Moscow, Russian Federation, 127473
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Moscow, Russian Federation, 121552
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Moscow, Russian Federation, 119881
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Murmansk, Russian Federation, 183047
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Novosibirsk, Russian Federation, 630007
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Novosibirsk, Russian Federation, 630054
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Novosibirsk, Russian Federation, 630051
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Rostov-on-Don, Russian Federation, 344022
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Samara, Russian Federation, 443070
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Saratov, Russian Federation, 410028
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Saratov, Russian Federation, 410053
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Saratov, Russian Federation, 410054
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Smolensk, Russian Federation, 214018
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St. Petersburg, Russian Federation, 199106
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 196247
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St. Petersburg, Russian Federation, 192242
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St. Petersburg, Russian Federation, 198205
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St. Petersburg, Russian Federation, 195067
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St.Petersburg, Russian Federation, 191025
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Tomsk, Russian Federation, 643012
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Yaroslavl, Russian Federation, 150003
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Yaroslavl, Russian Federation, 150030
Singapore
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Singapore, Singapore, 169608
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Singapore, Singapore, 119074
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Singapore, Singapore, 169609
South Africa
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Johannesburg, Gauteng, South Africa, 2021
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Johannesburg, Gauteng, South Africa, 2193
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Cape Town, Western Cape, South Africa, 7530
Recruiting
Pretoria, South Africa, Gauteng 0084
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Worcester, South Africa, 6850
Spain
Recruiting
Barcelona, Cataluña, Spain, 08003
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Barcelona, Cataluña, Spain, 08036
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L'Hospitalet de Llobregat, Cataluña, Spain, 08907
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Sabadell, Cataluña, Spain, 08208
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Sant Boi de Llobregat, Cataluña, Spain, '08830
Recruiting
Tarragona, Cataluña, Spain, 43007
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Madrid, Communidad de, Spain, 28007
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Orihuela, Comunidad Valenciana, Spain, 03314
Recruiting
Vigo, Galicia, Spain, 36204
Recruiting
Madrid, Madrid, Communidad de, Spain, 28034
Recruiting
Majadahonda, Madrid, Communidad de, Spain, 28222
Recruiting
San Sebastián de los Reyes, Madrid, Communidad de, Spain, 28702
Recruiting
Barcelona, Spain, 08023
Recruiting
Barcelona, Spain, 08041
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Cartagena, Spain, 30202
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Girona, Spain, 17007
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Olot, Spain, 17800
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Pontevedra, Spain, 36001
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Salamanca, Spain, 37007
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Terrassa, Spain, 08221
Ukraine
Recruiting
Donetsk, Ukraine, 83045
Recruiting
Donetsk, Ukraine, 83114
Recruiting
Ivano-Frankivsk, Ukraine
Active, not recruiting
Ivano-Frankivsk, Ukraine, 76008
Recruiting
Kharkiv, Ukraine, 61039
Recruiting
Kharkiv, Ukraine, 61176
Active, not recruiting
Kharkiv, Ukraine, 61039
Recruiting
Kharkiv, Ukraine, 61018
Active, not recruiting
Kharkiv,, Ukraine, 61058
Recruiting
Kherson, Ukraine, 73039
Recruiting
Kirovograd, Ukraine, 25006
Recruiting
Kyiv, Ukraine, 04060
Recruiting
Kyiv, Ukraine, 02660
Recruiting
Kyiv, Ukraine, 01023
Recruiting
Kyiv, Ukraine, 03680
Recruiting
Kyiv, Ukraine, 02091
Recruiting
Lugansk, Ukraine, 91011
Recruiting
Lutsk, Ukraine, 43024
Recruiting
Lviv, Ukraine, 79010
Recruiting
Odesa, Ukraine, 65009
Recruiting
Odesa, Ukraine, 65025
Active, not recruiting
Odesa, Ukraine, 65014
Active, not recruiting
Rivne, Ukraine, 33001
Recruiting
Simferopol, Ukraine, 95026
Recruiting
Uzhgorod, Ukraine, 88000
Active, not recruiting
Vinnytsya, Ukraine, 21005
Active, not recruiting
Yevpatoriya, Ukraine, 97400
Recruiting
Zaporizhzhya, Ukraine, 69000
Active, not recruiting
Zaporizhzhya, Ukraine, 69065
United Kingdom
Recruiting
London, United Kingdom, SE5 9RS
Recruiting
London, United Kingdom, EC1M 6BQ
Recruiting
London, United Kingdom, WC1E 6HX
Recruiting
Manchester, United Kingdom, M23 9LT
Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Recruiting
Romford, United Kingdom, RM7 0AG
Recruiting
Southall, United Kingdom, UB1 3HW
Sponsors and Collaborators
Portola Pharmaceuticals
  More Information

No publications provided by Portola Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01583218     History of Changes
Other Study ID Numbers: 11-019
Study First Received: April 16, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Phase III

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
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 July 22, 2014