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Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

8 maggio 2014 aggiornato da: Boehringer Ingelheim

A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2867

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Adrogué, Argentina
        • 1160.47.54017 Boehringer Ingelheim Investigational Site
      • Bahía Blanca, Argentina
        • 1160.47.54015 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54001 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54003 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54005 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54006 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54007 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1160.47.54010 Boehringer Ingelheim Investigational Site
      • La Plata, Argentina
        • 1160.47.54016 Boehringer Ingelheim Investigational Site
      • Mar del Plata, Argentina
        • 1160.47.54014 Boehringer Ingelheim Investigational Site
      • Quilmes, Argentina
        • 1160.47.54013 Boehringer Ingelheim Investigational Site
      • Rosario, Argentina
        • 1160.47.54011 Boehringer Ingelheim Investigational Site
      • Salta, Argentina
        • 1160.47.54018 Boehringer Ingelheim Investigational Site
      • Santa Fe, Argentina
        • 1160.47.54012 Boehringer Ingelheim Investigational Site
  • Australia
    • Queensland
      • Wooloongabba, Queensland, Australia
        • 1160.47.61002 Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia
        • 1160.47.61004 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 1160.47.61003 Boehringer Ingelheim Investigational Site
      • Clayton, Victoria, Australia
        • 1160.47.61001 Boehringer Ingelheim Investigational Site
      • Windsor, Victoria, Australia
        • 1160.47.61006 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • 1160.47.61005 Boehringer Ingelheim Investigational Site
  • Austria
      • Graz, Austria
        • 1160.47.43001 Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • 1160.47.43003 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.47.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1160.47.43004 Boehringer Ingelheim Investigational Site
  • Belgio
      • Bruxelles, Belgio
        • 1160.47.32001 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgio
        • 1160.47.32002 Boehringer Ingelheim Investigational Site
      • Leuven, Belgio
        • 1160.47.32005 Boehringer Ingelheim Investigational Site
      • Liège, Belgio
        • 1160.47.32004 Boehringer Ingelheim Investigational Site
  • Brasile
      • Brasília, Brasile
        • 1160.47.55010 Boehringer Ingelheim Investigational Site
      • Campinas - SP, Brasile
        • 1160.47.55007 Boehringer Ingelheim Investigational Site
      • Curitiba, Brasile
        • 1160.47.55014 Boehringer Ingelheim Investigational Site
      • Juvene - Paraná -, Brasile
        • 1160.47.55017 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro - RJ, Brasile
        • 1160.47.55016 Boehringer Ingelheim Investigational Site
      • São Bernardo do Campo, Brasile
        • 1160.47.55018 Boehringer Ingelheim Investigational Site
      • São José do Rio Preto, Brasile
        • 1160.47.55005 Boehringer Ingelheim Investigational Site
      • pTO aLEGRE, Brasile
        • 1160.47.55012 Boehringer Ingelheim Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • 1160.47.35910 Boehringer Ingelheim Investigational Site
      • Rousse, Bulgaria
        • 1160.47.35908 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.47.35901 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.47.35903 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.47.35904 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.47.35906 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.47.35907 Boehringer Ingelheim Investigational Site
      • Varna, Bulgaria
        • 1160.47.35905 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • 1160.47.02006 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1160.47.02013 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • 1160.47.02021 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint Johns, New Brunswick, Canada
        • 1160.47.02004 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1160.47.02001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1160.47.02002 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.47.02005 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.47.02010 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.47.02022 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1160.47.02015 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1160.47.02019 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1160.47.02008 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.47.02009 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.47.02014 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.47.02017 Boehringer Ingelheim Investigational Site
  • Cina
      • Beijing, Cina
        • 1160.47.86001 Boehringer Ingelheim Investigational Site
      • Beijing, Cina
        • 1160.47.86015 Boehringer Ingelheim Investigational Site
      • Chengdu, Cina
        • 1160.47.86014 Boehringer Ingelheim Investigational Site
      • Guangzhou, Cina
        • 1160.47.86012 Boehringer Ingelheim Investigational Site
      • Hangzhou, Cina
        • 1160.47.86009 Boehringer Ingelheim Investigational Site
      • Hangzhou, Cina
        • 1160.47.86010 Boehringer Ingelheim Investigational Site
      • Nanjing, Cina
        • 1160.47.86013 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86002 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86003 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86006 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86007 Boehringer Ingelheim Investigational Site
      • Shanghai, Cina
        • 1160.47.86016 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, Cina
        • 1160.47.86011 Boehringer Ingelheim Investigational Site
  • Danimarca
      • Esbjerg, Danimarca
        • 1160.47.45008 Boehringer Ingelheim Investigational Site
      • Holbæk, Danimarca
        • 1160.47.45009 Boehringer Ingelheim Investigational Site
      • Kolding, Danimarca
        • 1160.47.45002 Boehringer Ingelheim Investigational Site
      • København NV, Danimarca
        • 1160.47.45004 Boehringer Ingelheim Investigational Site
      • København S, Danimarca
        • 1160.47.45007 Boehringer Ingelheim Investigational Site
      • Slagelse, Danimarca
        • 1160.47.45006 Boehringer Ingelheim Investigational Site
  • Federazione Russa
      • Belgorod, Federazione Russa
        • 1160.47.07022 Boehringer Ingelheim Investigational Site
      • Chelyabinsk, Federazione Russa
        • 1160.47.07011 Boehringer Ingelheim Investigational Site
      • Chelyabinsk, Federazione Russa
        • 1160.47.07021 Boehringer Ingelheim Investigational Site
      • Ekaterinburg, Federazione Russa
        • 1160.47.07007 Boehringer Ingelheim Investigational Site
      • Krasnodar, Federazione Russa
        • 1160.47.07016 Boehringer Ingelheim Investigational Site
      • Kursk, Federazione Russa
        • 1160.47.07004 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Federazione Russa
        • 1160.47.07010 Boehringer Ingelheim Investigational Site
      • Omsk, Federazione Russa
        • 1160.47.07020 Boehringer Ingelheim Investigational Site
      • Pskov, Federazione Russa
        • 1160.47.07018 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federazione Russa
        • 1160.47.07009 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federazione Russa
        • 1160.47.07023 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federazione Russa
        • 1160.47.07024 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federazione Russa
        • 1160.47.07025 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Federazione Russa
        • 1160.47.07001 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Federazione Russa
        • 1160.47.07002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Federazione Russa
        • 1160.47.07017 Boehringer Ingelheim Investigational Site
      • Tyumen, Federazione Russa
        • 1160.47.07019 Boehringer Ingelheim Investigational Site
      • Ufa, Federazione Russa
        • 1160.47.07014 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Federazione Russa
        • 1160.47.07005 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Federazione Russa
        • 1160.47.07006 Boehringer Ingelheim Investigational Site
  • Finlandia
      • Espoo, Finlandia
        • 1160.47.35804 Boehringer Ingelheim Investigational Site
      • Helsinki, Finlandia
        • 1160.47.35801 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finlandia
        • 1160.47.35802 Boehringer Ingelheim Investigational Site
      • Kuopio, Finlandia
        • 1160.47.35805 Boehringer Ingelheim Investigational Site
      • Tampere, Finlandia
        • 1160.47.35803 Boehringer Ingelheim Investigational Site
  • Francia
      • Brest Cedex, Francia
        • 1160.47.3301A Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301B Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301C Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301D Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301E Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301F Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301H Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.47.3301I Boehringer Ingelheim Investigational Site
      • Lorient, Francia
        • 1160.47.3302A Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.47.3303A Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.47.3303B Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.47.3303C Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.47.3303D Boehringer Ingelheim Investigational Site
      • Vandoeuvre les Nancy, Francia
        • 1160.47.3308A Boehringer Ingelheim Investigational Site
  • Germania
      • Dresden, Germania
        • 1160.47.49017 Boehringer Ingelheim Investigational Site
      • Dresden, Germania
        • 1160.47.49018 Boehringer Ingelheim Investigational Site
      • Köln, Germania
        • 1160.47.49003 Boehringer Ingelheim Investigational Site
      • Mannheim, Germania
        • 1160.47.49005 Boehringer Ingelheim Investigational Site
      • Mannheim, Germania
        • 1160.47.49006 Boehringer Ingelheim Investigational Site
      • München, Germania
        • 1160.47.49007 Boehringer Ingelheim Investigational Site
      • München, Germania
        • 1160.47.49008 Boehringer Ingelheim Investigational Site
      • Püttlingen, Germania
        • 1160.47.49009 Boehringer Ingelheim Investigational Site
  • Grecia
      • Athens, Grecia
        • 1160.47.30001 Boehringer Ingelheim Investigational Site
      • Athens, Grecia
        • 1160.47.30006 Boehringer Ingelheim Investigational Site
      • Athens, Grecia
        • 1160.47.30007 Boehringer Ingelheim Investigational Site
      • Athens, Grecia
        • 1160.47.30009 Boehringer Ingelheim Investigational Site
  • India
      • Ahmedabad, India
        • 1160.47.91002 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1160.47.91011 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1160.47.91015 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1160.47.91012 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1160.47.91017 Boehringer Ingelheim Investigational Site
      • Madurai, India
        • 1160.47.91009 Boehringer Ingelheim Investigational Site
      • Mysore, India
        • 1160.47.91007 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1160.47.91003 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1160.47.91010 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.47.91001 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.47.91005 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.47.91008 Boehringer Ingelheim Investigational Site
      • Trivandrum, India
        • 1160.47.91014 Boehringer Ingelheim Investigational Site
      • Vadodara, India
        • 1160.47.91004 Boehringer Ingelheim Investigational Site
      • new Delhi, India
        • 1160.47.91006 Boehringer Ingelheim Investigational Site
  • Israele
      • Afula, Israele
        • 1160.47.97202 Boehringer Ingelheim Investigational Site
      • Ashkelon, Israele
        • 1160.47.97207 Boehringer Ingelheim Investigational Site
      • Haifa, Israele
        • 1160.47.97211 Boehringer Ingelheim Investigational Site
      • Holon, Israele
        • 1160.47.97203 Boehringer Ingelheim Investigational Site
      • Kfar Saba, Israele
        • 1160.47.97205 Boehringer Ingelheim Investigational Site
      • Petach Tikva, Israele
        • 1160.47.97206 Boehringer Ingelheim Investigational Site
      • Rehovot, Israele
        • 1160.47.97208 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israele
        • 1160.47.97210 Boehringer Ingelheim Investigational Site
      • Tel Hashomer, Israele
        • 1160.47.97204 Boehringer Ingelheim Investigational Site
      • Zerifin, Israele
        • 1160.47.97201 Boehringer Ingelheim Investigational Site
  • Italia
      • Bologna, Italia
        • 1160.47.39003 Boehringer Ingelheim Investigational Site
      • Cremona, Italia
        • 1160.47.39004 Boehringer Ingelheim Investigational Site
      • Genova, Italia
        • 1160.47.39006 Boehringer Ingelheim Investigational Site
      • Milano, Italia
        • 1160.47.39008 Boehringer Ingelheim Investigational Site
      • Reggio Emilia, Italia
        • 1160.47.39007 Boehringer Ingelheim Investigational Site
      • Udine, Italia
        • 1160.47.39009 Boehringer Ingelheim Investigational Site
      • Vittorio Veneto, Italia
        • 1160.47.39005 Boehringer Ingelheim Investigational Site
  • Messico
      • Chihuahua, Messico
        • 1160.47.52036 Boehringer Ingelheim Investigational Site
      • Culiacan, Messico
        • 1160.47.52039 Boehringer Ingelheim Investigational Site
      • Guadalajara, Jal., Messico
        • 1160.47.52030 Boehringer Ingelheim Investigational Site
      • Monterrey, Messico
        • 1160.47.52027 Boehringer Ingelheim Investigational Site
      • San Luis Potosí, Messico
        • 1160.47.52034 Boehringer Ingelheim Investigational Site
  • Norvegia
      • Oslo, Norvegia
        • 1160.47.47001 Boehringer Ingelheim Investigational Site
      • Oslo, Norvegia
        • 1160.47.47004 Boehringer Ingelheim Investigational Site
      • Rud, Norvegia
        • 1160.47.47003 Boehringer Ingelheim Investigational Site
      • Trondheim, Norvegia
        • 1160.47.47005 Boehringer Ingelheim Investigational Site
  • Nuova Zelanda
      • Christchurch, Nuova Zelanda
        • 1160.47.64004 Boehringer Ingelheim Investigational Site
      • Grafton, Nuova Zelanda
        • 1160.47.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, Nuova Zelanda
        • 1160.47.64002 Boehringer Ingelheim Investigational Site
      • Takapuna Auckland 9, Nuova Zelanda
        • 1160.47.64001 Boehringer Ingelheim Investigational Site
  • Olanda
      • Amersfoort, Olanda
        • 1160.47.31001 Boehringer Ingelheim Investigational Site
      • Amsterdam, Olanda
        • 1160.47.31006 Boehringer Ingelheim Investigational Site
      • Amsterdam, Olanda
        • 1160.47.31007 Boehringer Ingelheim Investigational Site
      • Den Bosch, Olanda
        • 1160.47.31010 Boehringer Ingelheim Investigational Site
      • Heerlen, Olanda
        • 1160.47.31014 Boehringer Ingelheim Investigational Site
      • Maastricht, Olanda
        • 1160.47.31005 Boehringer Ingelheim Investigational Site
      • Rotterdam, Olanda
        • 1160.47.31004 Boehringer Ingelheim Investigational Site
      • Rotterdam, Olanda
        • 1160.47.31009 Boehringer Ingelheim Investigational Site
  • Polonia
      • Kielce, Polonia
        • 1160.47.48004 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.47.48005 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.47.48007 Boehringer Ingelheim Investigational Site
      • Poznan, Polonia
        • 1160.47.48003 Boehringer Ingelheim Investigational Site
      • Warsaw, Polonia
        • 1160.47.48006 Boehringer Ingelheim Investigational Site
  • Portogallo
      • Almada, Portogallo
        • 1160.47.35104 Boehringer Ingelheim Investigational Site
      • Coimbra, Portogallo
        • 1160.47.35109 Boehringer Ingelheim Investigational Site
      • Covilhã, Portogallo
        • 1160.47.35107 Boehringer Ingelheim Investigational Site
      • Lisboa, Portogallo
        • 1160.47.35101 Boehringer Ingelheim Investigational Site
      • Lisboa, Portogallo
        • 1160.47.35102 Boehringer Ingelheim Investigational Site
      • Lisboa, Portogallo
        • 1160.47.35105 Boehringer Ingelheim Investigational Site
  • Regno Unito
      • Headington, Oxford, Regno Unito
        • 1160.47.44005 Boehringer Ingelheim Investigational Site
      • London, Regno Unito
        • 1160.47.44009 Boehringer Ingelheim Investigational Site
      • London, Regno Unito
        • 1160.47.44011 Boehringer Ingelheim Investigational Site
      • Newcastle upon Tyne, Regno Unito
        • 1160.47.44006 Boehringer Ingelheim Investigational Site
      • Sheffield, Regno Unito
        • 1160.47.44012 Boehringer Ingelheim Investigational Site
  • Repubblica Ceca
      • Brno, Repubblica Ceca
        • 1160.47.42001 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Repubblica Ceca
        • 1160.47.42002 Boehringer Ingelheim Investigational Site
      • Hranice, Repubblica Ceca
        • 1160.47.42011 Boehringer Ingelheim Investigational Site
      • Liberec, Repubblica Ceca
        • 1160.47.42012 Boehringer Ingelheim Investigational Site
      • Novy Jicin, Repubblica Ceca
        • 1160.47.42015 Boehringer Ingelheim Investigational Site
      • Ostrava-Vitkovice, Repubblica Ceca
        • 1160.47.42005 Boehringer Ingelheim Investigational Site
      • Praha 2, Repubblica Ceca
        • 1160.47.42004 Boehringer Ingelheim Investigational Site
      • Tabor, Repubblica Ceca
        • 1160.47.42014 Boehringer Ingelheim Investigational Site
      • Usti nad Labem, Repubblica Ceca
        • 1160.47.42010 Boehringer Ingelheim Investigational Site
      • Zlin, Repubblica Ceca
        • 1160.47.42007 Boehringer Ingelheim Investigational Site
  • Slovacchia
      • Banska Bystrica, Slovacchia
        • 1160.47.42107 Boehringer Ingelheim Investigational Site
      • Lucenec, Slovacchia
        • 1160.47.42106 Boehringer Ingelheim Investigational Site
      • Nitra, Slovacchia
        • 1160.47.42102 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Slovacchia
        • 1160.47.42103 Boehringer Ingelheim Investigational Site
      • Zilina, Slovacchia
        • 1160.47.42104 Boehringer Ingelheim Investigational Site
  • Spagna
      • Alicante, Spagna
        • 1160.47.34006 Boehringer Ingelheim Investigational Site
      • Badalona (Barcelona), Spagna
        • 1160.47.34012 Boehringer Ingelheim Investigational Site
      • Barcelona, Spagna
        • 1160.47.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spagna
        • 1160.47.34002 Boehringer Ingelheim Investigational Site
      • Cartagena. Murcia, Spagna
        • 1160.47.34007 Boehringer Ingelheim Investigational Site
      • Cuenca, Spagna
        • 1160.47.34003 Boehringer Ingelheim Investigational Site
      • Madrid, Spagna
        • 1160.47.34009 Boehringer Ingelheim Investigational Site
      • Santander, Spagna
        • 1160.47.34004 Boehringer Ingelheim Investigational Site
      • Valencia, Spagna
        • 1160.47.34011 Boehringer Ingelheim Investigational Site
  • Stati Uniti
    • Alabama
      • Mobile, Alabama, Stati Uniti
        • 1160.47.01035 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Stati Uniti
        • 1160.47.01056 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, Stati Uniti
        • 1160.47.01044 Boehringer Ingelheim Investigational Site
    • Georgia
      • Augusta, Georgia, Stati Uniti
        • 1160.47.01019 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, Stati Uniti
        • 1160.47.01008 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti
        • 1160.47.01014 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Roxbury Crossing, Massachusetts, Stati Uniti
        • 1160.47.01018 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, Stati Uniti
        • 1160.47.01023 Boehringer Ingelheim Investigational Site
    • Minnesota
      • St. Louis Park, Minnesota, Stati Uniti
        • 1160.47.01009 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti
        • 1160.47.01031 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti
        • 1160.47.01036 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti
        • 1160.47.01027 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, Stati Uniti
        • 1160.47.01039 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, Stati Uniti
        • 1160.47.01030 Boehringer Ingelheim Investigational Site
    • Ohio
      • Toledo, Ohio, Stati Uniti
        • 1160.47.01013 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Stati Uniti
        • 1160.47.01052 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Summerville, South Carolina, Stati Uniti
        • 1160.47.01055 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, Stati Uniti
        • 1160.47.01017 Boehringer Ingelheim Investigational Site
  • Sud Africa
      • Johannesburg, Sud Africa
        • 1160.47.27001 Boehringer Ingelheim Investigational Site
      • Johannesburg, Sud Africa
        • 1160.47.27002 Boehringer Ingelheim Investigational Site
      • Johannesburg, Sud Africa
        • 1160.47.27006 Boehringer Ingelheim Investigational Site
      • Pretoria, Sud Africa
        • 1160.47.27007
      • Randburg, Sud Africa
        • 1160.47.27003 Boehringer Ingelheim Investigational Site
      • Roodepoort, Sud Africa
        • 1160.47.27005 Boehringer Ingelheim Investigational Site
  • Svezia
      • Göteborg, Svezia
        • 1160.47.46002 Boehringer Ingelheim Investigational Site
      • Jönköping, Svezia
        • 1160.47.46006 Boehringer Ingelheim Investigational Site
      • Stockholm, Svezia
        • 1160.47.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Svezia
        • 1160.47.46007 Boehringer Ingelheim Investigational Site
      • Stockholm, Svezia
        • 1160.47.46008 Boehringer Ingelheim Investigational Site
      • Sundsvall, Svezia
        • 1160.47.46005 Boehringer Ingelheim Investigational Site
      • Uppsala, Svezia
        • 1160.47.46003 Boehringer Ingelheim Investigational Site
  • Tacchino
      • Ankara, Tacchino
        • 1160.47.90003 Boehringer Ingelheim Investigational Site
      • Ankara, Tacchino
        • 1160.47.90004 Boehringer Ingelheim Investigational Site
      • Ankara, Tacchino
        • 1160.47.90005 Boehringer Ingelheim Investigational Site
      • Istanbul, Tacchino
        • 1160.47.90001 Boehringer Ingelheim Investigational Site
      • Istanbul, Tacchino
        • 1160.47.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Tacchino
        • 1160.47.90007 Boehringer Ingelheim Investigational Site
      • Izmir, Tacchino
        • 1160.47.90006 Boehringer Ingelheim Investigational Site
  • Ucraina
      • Kharkov, Ucraina
        • 1160.47.38002 Boehringer Ingelheim Investigational Site
      • Kiev, Ucraina
        • 1160.47.38006 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ucraina
        • 1160.47.38005 Boehringer Ingelheim Investigational Site
      • Zaporozhye, Ucraina
        • 1160.47.38003 Boehringer Ingelheim Investigational Site
  • Ungheria
      • Budapest, Ungheria
        • 1160.47.36001 Boehringer Ingelheim Investigational Site
      • Budapest, Ungheria
        • 1160.47.36006 Boehringer Ingelheim Investigational Site
      • Budapest, Ungheria
        • 1160.47.36007 Boehringer Ingelheim Investigational Site
      • Debrecen, Ungheria
        • 1160.47.36002 Boehringer Ingelheim Investigational Site
      • Gyula, Ungheria
        • 1160.47.36012 Boehringer Ingelheim Investigational Site
      • Miskolc, Ungheria
        • 1160.47.36004 Boehringer Ingelheim Investigational Site
      • Pecs, Ungheria
        • 1160.47.36003 Boehringer Ingelheim Investigational Site
      • Szombathely, Ungheria
        • 1160.47.36011 Boehringer Ingelheim Investigational Site
      • Székesfehérvár, Ungheria
        • 1160.47.36010 Boehringer Ingelheim Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

Inclusion_Criteria

  • Acute symptomatic deep vein thrombosis (DVT)
  • Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

  • Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
  • Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
  • Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Droga: Dabigatran
Dabigatran 150 mg BID (twice daily)
Comparatore attivo: Warfarin (INR of 2.0-3.0)
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Droga: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite of Recurrent VTE or VTE Death at 36 Months
Lasso di tempo: 36 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
36 months
Composite of Recurrent VTE or VTE Death at 18 Months
Lasso di tempo: 18 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
18 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite of Recurrent VTE or All Cause Death at 36 Months
Lasso di tempo: 36 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
36 months
Composite of Recurrent VTE or All Cause Death at 18 Months
Lasso di tempo: 18 months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
18 months
Deep Vein Thrombosis (DVT) at 36 Months
Lasso di tempo: 36 months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
36 months
DVT at 18 Months
Lasso di tempo: 18 months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
18 months
Symptomatic Pulmonary Embolism (PE) at 36 Months
Lasso di tempo: 36 months
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
36 months
Symptomatic Pulmonary Embolism (PE) at 18 Months
Lasso di tempo: 18 months
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
18 months
Deaths Related to VTE at 36 Months
Lasso di tempo: 36 months
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
36 months
Deaths Related to VTE at 18 Months
Lasso di tempo: 18 months
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
18 months
Deaths of All Causes at 36 Months
Lasso di tempo: 36 months
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
36 months
Deaths of All Causes at 18 Months
Lasso di tempo: 18 months
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
18 months
Number of Participants With Bleeding Events
Lasso di tempo: first intake of study drug until 6 days following last intake of study drug

MBE (major bleeding event) if it fulfilled at least one of the following criteria

  • Fatal bleeding
  • Symptomatic bleeding in a critical area or organ.
  • Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.

Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

  • Spontaneous skin haematoma ≥25 cm2
  • Spontaneous nose bleed >5 min duration
  • Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
  • Spontaneous rectal bleeding
  • Gingival bleeding >5 min
  • Bleeding leading to hospitalisation or requiring surgical treatment
  • Bleeding leading to a transfusion of <2 units of whole blood or red cells
  • Any other bleeding event considered clinically relevant by the investigator
first intake of study drug until 6 days following last intake of study drug
Laboratory Analysis
Lasso di tempo: 18 months + 30 days follow up
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
18 months + 30 days follow up
Number of Participants With Definite Acute Coronary Syndrome (ACS)
Lasso di tempo: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2006

Completamento primario (Effettivo)

1 ottobre 2010

Date di iscrizione allo studio

Primo inviato

23 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

23 maggio 2006

Primo Inserito (Stima)

24 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2014

Ultimo verificato

1 dicembre 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1160.47
  • 2005-002536-94 (Numero EudraCT: EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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