A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

Last updated: October 5, 2015
Sponsor: Astellas Pharma Europe B.V.
Overall Status: Completed

Phase

2/3

Condition

Blood Clots

Venous Thrombosis

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT00902928
150-CL-040
2008-004416-13
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is scheduled for elective hip replacement surgery

Exclusion

Exclusion Criteria:

  • Subject has active bleeding or any condition associated with increased risk ofbleeding

  • Subject has had major trauma or surgery within 3 months before planned hip replacementsurgery or requires major surgery or other invasive procedures with potential foruncontrolled bleeding during the study

  • Subject has had an MI or stroke within 3 months before planned hip replacement surgery

Study Design

Total Participants: 1992
Study Start date:
April 01, 2009
Estimated Completion Date:
August 31, 2010

Connect with a study center

  • Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Ringwood East, Victoria 3135
    Australia

    Site Not Available

  • Windsor, Victoria 3181
    Australia

    Site Not Available

  • Perth, Western Australia 6000
    Australia

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  • Kogarah, 2217
    Australia

    Site Not Available

  • Graz, 8036
    Austria

    Site Not Available

  • Innsbruck, A-6020
    Austria

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  • Linz, 4010
    Austria

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  • Vienna, 1090
    Austria

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  • Foca, 73300
    Bosnia and Herzegovina

    Site Not Available

  • Porto Alegre, Rio Grande do Sul 30130-100
    Brazil

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  • Sao Paulo, So Paulo 04262-000
    Brazil

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  • Red Deer, Alberta T4N 6V7
    Canada

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  • Burlington, Ontario L7R 4B7
    Canada

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  • Guelph, Ontario N1E 6L9
    Canada

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  • Newmarket, Ontario L3Y 2P9
    Canada

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  • Thunder Bay, Ontario P7B 6V4
    Canada

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  • Waterloo, Ontario N2J 1CA
    Canada

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  • Medellin, Antioquia
    Colombia

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  • Bogota, Cundinamarca
    Colombia

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  • Floridablanca, Santander
    Colombia

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  • Barranquilla,
    Colombia

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  • Brno, 66250
    Czech Republic

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  • Chomutov, 43001
    Czech Republic

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  • Havlickuv Brod, 580 22
    Czech Republic

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  • Jihlava, 58633
    Czech Republic

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  • Jindrichuv Hradec, 37738
    Czech Republic

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  • Klatovy, 33938
    Czech Republic

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  • Liberec, 46001
    Czech Republic

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  • Prague, 18081
    Czech Republic

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  • Trebic, 67401
    Czech Republic

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  • Copenhagen, 2400
    Denmark

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  • Frederiksberg, 2000
    Denmark

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  • Herlev, 2730
    Denmark

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  • Horsholm, 2970
    Denmark

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  • Silkeborg, 8600
    Denmark

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  • Kohtla-Jarve, 30322
    Estonia

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  • Tallinn, 10611
    Estonia

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  • Tartu, 51014
    Estonia

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  • Jyvaskyla, 40620
    Finland

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  • Oulu, 90029
    Finland

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  • Mainz, 55101
    Germany

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  • Marburg, 35033
    Germany

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  • Budapest, 1113
    Hungary

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  • Debrecen, 4012
    Hungary

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  • Gyor, 9023
    Hungary

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  • Kecskemet, 6000
    Hungary

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  • Szeged, 6725
    Hungary

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  • Szekesfehervar, 8000
    Hungary

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  • Szekszard, 7100
    Hungary

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  • Szolnok, 5000
    Hungary

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  • Hyderabaad, Andhra Pradesh 500034
    India

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  • Secunderabad, Andhra Prasdesh 500003
    India

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  • Baroda, Gujarat 390007
    India

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  • Gurgaon, Haryana 122001
    India

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  • Jamshedpur, Jharkhand 831004
    India

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  • Bangalore, Karnataka 560054
    India

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  • Kormangala, Karnataka 5600034
    India

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  • Mangalore, Karnataka 575001
    India

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  • Bhopal, Madhya Pradesh 462010
    India

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  • Jaipur, Rajasthan 302004
    India

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  • Afula, 18101
    Israel

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  • Haifa, 31096
    Israel

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  • Kfar Saba, 44281
    Israel

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  • Petach Tikva, 49100
    Israel

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  • Rehovot, 76100
    Israel

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  • Bologna, 40136
    Italy

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  • Milano, 20132
    Italy

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  • Daugavpils, LV4317
    Latvia

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  • Liepaja, LV 3400
    Latvia

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  • Riga, LV1004
    Latvia

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  • Valmiera, LV4201
    Latvia

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  • Kaunas, LT-44320
    Lithuania

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  • Klaipeda, 92288
    Lithuania

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  • Vilnius, 04130
    Lithuania

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  • Gjovik, 2819
    Norway

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  • Kongsvinger, 2226
    Norway

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  • Lillehammer, 2629
    Norway

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  • Tonsberg, 3116
    Norway

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  • Tynset, 2500
    Norway

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  • Glogow Malopolski, 36-060
    Poland

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  • Konskie, 26-200
    Poland

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  • Krakow, 31-913
    Poland

    Site Not Available

  • Lodz, 91-002
    Poland

    Site Not Available

  • Lublin, 20-718
    Poland

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  • Opole, 45-372
    Poland

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  • Otwock, 05-400
    Poland

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  • Poznan, 61-485
    Poland

    Site Not Available

  • Warszawa, 02-005
    Poland

    Site Not Available

  • Curitiba, 80060-900
    Puerto Rico

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  • Timisoara, Timis 300736
    Romania

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  • Bucharest, 021382
    Romania

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  • Cluj, 0400132
    Romania

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  • Craiova, 20116
    Romania

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  • Iasi, 0700483
    Romania

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  • Kazan, 420012
    Russian Federation

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  • Moscow, 119049
    Russian Federation

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  • Nizhny Novgorod, 603155
    Russian Federation

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  • Novosibirsk, 630091
    Russian Federation

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  • Omsk, 644043
    Russian Federation

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  • Samara, 443095
    Russian Federation

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  • St. Petersburg, 194354
    Russian Federation

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  • Yaroslavl, 150003
    Russian Federation

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  • Banska Bysterica, 975 01
    Slovakia

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  • Kosice Saca, 04015
    Slovakia

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  • Presov, 08181
    Slovakia

    Site Not Available

  • Worcester, Cape Town 6850
    South Africa

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  • Benoni, 1501
    South Africa

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  • Bryanston, 2021
    South Africa

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  • Port Elizabeth, 6014
    South Africa

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  • Pretoria, 0083
    South Africa

    Site Not Available

  • Barcelona, 08036
    Spain

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  • Castello, 12004
    Spain

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  • Madrid, 28006
    Spain

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  • Palma Mallorca, 07014
    Spain

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  • Kalmar, 391 85
    Sweden

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  • Molndal, 41685
    Sweden

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  • Motala, 591 85
    Sweden

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  • Stockholm, 182 88
    Sweden

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  • Varberg, 43281
    Sweden

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  • Cherkassy, 18009
    Ukraine

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  • Ivano-Frankovsk, 76008
    Ukraine

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  • Lviv, 79495
    Ukraine

    Site Not Available

  • Sevastopol, 99018
    Ukraine

    Site Not Available

  • Epsom, Surrey KT18 7EG
    United Kingdom

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  • London, SE5 9RS
    United Kingdom

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  • Northampton, NN1 5 BD
    United Kingdom

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  • Phoenix, Arizona 85050
    United States

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  • Tuscon, Arizona 85712
    United States

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  • Little Rock, Arkansas 72205
    United States

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  • Long Beach, California 90806
    United States

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  • Torrance, California 90507
    United States

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  • Aurora, Colorado 80015
    United States

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  • DeLand, Florida 32720
    United States

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  • Pinellas Park, Florida 33781
    United States

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  • Sarasota, Florida 34239
    United States

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  • Tamarac, Florida 33321
    United States

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  • Meridian, Idaho 83642
    United States

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  • Lexington, Kentucky 40509
    United States

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  • Baltimore, Maryland 21215
    United States

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  • Charleston, South Carolina 29414
    United States

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  • Austin, Texas 78745
    United States

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  • Dallas, Texas 75231
    United States

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  • Houston, Texas 77024
    United States

    Site Not Available

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