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Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

8 de mayo de 2014 actualizado por: Boehringer Ingelheim

A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2589

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • 1160.46.61007 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 1160.46.61003 Boehringer Ingelheim Investigational Site
      • Clayton, Victoria, Australia
        • 1160.46.61001 Boehringer Ingelheim Investigational Site
      • Windsor, Victoria, Australia
        • 1160.46.61006 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • 1160.46.61005 Boehringer Ingelheim Investigational Site
  • Brasil
      • Brasília, Brasil
        • 1160.46.55010 Boehringer Ingelheim Investigational Site
      • Campinas, Brasil
        • 1160.46.55007 Boehringer Ingelheim Investigational Site
      • Curitiba, Brasil
        • 1160.46.55014 Boehringer Ingelheim Investigational Site
      • Curitiba, Brasil
        • 1160.46.55017 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brasil
        • 1160.46.55019 Boehringer Ingelheim Investigational Site
      • Recife, Brasil
        • 1160.46.55021 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro - RJ, Brasil
        • 1160.46.55016 Boehringer Ingelheim Investigational Site
      • São Bernardo do Campo, Brasil
        • 1160.46.55018 Boehringer Ingelheim Investigational Site
      • São Paulo, Brasil
        • 1160.46.55020 Boehringer Ingelheim Investigational Site
  • Bulgaria
      • Sofia, Bulgaria
        • 1160.46.35901 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.46.35903 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1160.46.35906 Boehringer Ingelheim Investigational Site
      • Varna, Bulgaria
        • 1160.46.35905 Boehringer Ingelheim Investigational Site
  • Canadá
      • Quebec, Canadá
        • 1160.46.02020 Boehringer Ingelheim Investigational Site
    • Alberta
      • Edmonton, Alberta, Canadá
        • 1160.46.02006 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canadá
        • 1160.46.02013 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canadá
        • 1160.46.02021 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canadá
        • 1160.46.02004 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá
        • 1160.46.02001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canadá
        • 1160.46.02002 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canadá
        • 1160.46.02005 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canadá
        • 1160.46.02010 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canadá
        • 1160.46.02015 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canadá
        • 1160.46.02019 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá
        • 1160.46.02008 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canadá
        • 1160.46.02009 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canadá
        • 1160.46.02014 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canadá
        • 1160.46.02017 Boehringer Ingelheim Investigational Site
  • Corea, república de
      • Busan, Corea, república de
        • 1160.46.82007 Boehringer Ingelheim Investigational Site
      • Goyang-si, Corea, república de
        • 1160.46.82003 Boehringer Ingelheim Investigational Site
      • Gyeonggi-do, Corea, república de
        • 1160.46.82008 Boehringer Ingelheim Investigational Site
      • Gyeonggi-do, Corea, república de
        • 1160.46.82010 Boehringer Ingelheim Investigational Site
      • Kyunggi-do, Corea, república de
        • 1160.46.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Corea, república de
        • 1160.46.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Corea, república de
        • 1160.46.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Corea, república de
        • 1160.46.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Corea, república de
        • 1160.46.82009 Boehringer Ingelheim Investigational Site
  • Dinamarca
      • Aarhus C, Dinamarca
        • 1160.46.45001 Boehringer Ingelheim Investigational Site
      • Esbjerg, Dinamarca
        • 1160.46.45008 Boehringer Ingelheim Investigational Site
      • Holbæk, Dinamarca
        • 1160.46.45009 Boehringer Ingelheim Investigational Site
      • København NV, Dinamarca
        • 1160.46.45004 Boehringer Ingelheim Investigational Site
  • Eslovaquia
      • Banska Bystrica, Eslovaquia
        • 1160.46.42107 Boehringer Ingelheim Investigational Site
      • Lucenec, Eslovaquia
        • 1160.46.42106 Boehringer Ingelheim Investigational Site
      • Nitra, Eslovaquia
        • 1160.46.42102 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Eslovaquia
        • 1160.46.42103 Boehringer Ingelheim Investigational Site
  • España
      • Barcelona, España
        • 1160.46.34002 Boehringer Ingelheim Investigational Site
      • Cartagena. Murcia, España
        • 1160.46.34007 Boehringer Ingelheim Investigational Site
      • Madrid, España
        • 1160.46.34009 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, España
        • 1160.46.34015 Boehringer Ingelheim Investigational Site
      • Sabadell - barcelona, España
        • 1160.46.34014 Boehringer Ingelheim Investigational Site
      • Valencia, España
        • 1160.46.34011 Boehringer Ingelheim Investigational Site
  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos
        • 1160.46.01073 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, Estados Unidos
        • 1160.46.01044 Boehringer Ingelheim Investigational Site
    • Illinois
      • Normal, Illinois, Estados Unidos
        • 1160.46.01068 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos
        • 1160.46.01071 Boehringer Ingelheim Investigational Site
    • New York
      • Stony Brook, New York, Estados Unidos
        • 1160.46.01060 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, Estados Unidos
        • 1160.46.01061 Boehringer Ingelheim Investigational Site
    • Oregon
      • Bend, Oregon, Estados Unidos
        • 1160.46.01059 Boehringer Ingelheim Investigational Site
      • Corvallis, Oregon, Estados Unidos
        • 1160.46.01063 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Summerville, South Carolina, Estados Unidos
        • 1160.46.01055 Boehringer Ingelheim Investigational Site
    • Washington
      • Bellevue, Washington, Estados Unidos
        • 1160.46.01062 Boehringer Ingelheim Investigational Site
  • Federación Rusa
      • Chelyabinsk, Federación Rusa
        • 1160.46.07021 Boehringer Ingelheim Investigational Site
      • Ekaterinburg, Federación Rusa
        • 1160.46.07007 Boehringer Ingelheim Investigational Site
      • Krasnodar, Federación Rusa
        • 1160.46.07016 Boehringer Ingelheim Investigational Site
      • Kursk, Federación Rusa
        • 1160.46.07004 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federación Rusa
        • 1160.46.07009 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Federación Rusa
        • 1160.46.07024 Boehringer Ingelheim Investigational Site
      • Ufa, Federación Rusa
        • 1160.46.07014 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Federación Rusa
        • 1160.46.07005 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Federación Rusa
        • 1160.46.07006 Boehringer Ingelheim Investigational Site
  • Filipinas
      • Manila, Filipinas
        • 1160.46.63001 Boehringer Ingelheim Investigational Site
      • Muntinlupa, Filipinas
        • 1160.46.63005 Boehringer Ingelheim Investigational Site
      • Quezon City, Filipinas
        • 1160.46.63003 Boehringer Ingelheim Investigational Site
      • Quezon City, Filipinas
        • 1160.46.63004 Boehringer Ingelheim Investigational Site
  • Francia
      • Brest Cedex, Francia
        • 1160.46.3301A Boehringer Ingelheim Investigational Site
      • Brest Cedex, Francia
        • 1160.46.3301B Boehringer Ingelheim Investigational Site
      • La Roche-Sur-Yon cedex 09, Francia
        • 1160.46.3315A Boehringer Ingelheim Investigational Site
      • La Roche-Sur-Yon cedex 09, Francia
        • 1160.46.3315B Boehringer Ingelheim Investigational Site
      • Nantes, Francia
        • 1160.46.3313A Boehringer Ingelheim Investigational Site
      • Pessac, Francia
        • 1160.46.3316A Boehringer Ingelheim Investigational Site
      • Pessac, Francia
        • 1160.46.3316B Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303C Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303D Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303E Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303F Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303G Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, Francia
        • 1160.46.3303H Boehringer Ingelheim Investigational Site
      • St Priest En Jarez Cedex, Francia
        • 1160.46.3303A Boehringer Ingelheim Investigational Site
      • St Priest En Jarez Cedex, Francia
        • 1160.46.3303B Boehringer Ingelheim Investigational Site
  • Hungría
      • Debrecen, Hungría
        • 1160.46.36002 Boehringer Ingelheim Investigational Site
      • Szekesfehervar, Hungría
        • 1160.46.36010 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungría
        • 1160.46.36011 Boehringer Ingelheim Investigational Site
  • India
      • Bangalore, India
        • 1160.46.91006 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1160.46.91010 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1160.46.91002 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1160.46.91007 Boehringer Ingelheim Investigational Site
      • Kolkata, India
        • 1160.46.91012 Boehringer Ingelheim Investigational Site
      • Ludhiana, India
        • 1160.46.91009 Boehringer Ingelheim Investigational Site
      • Nagpur, India
        • 1160.46.91008 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1160.46.91005 Boehringer Ingelheim Investigational Site
      • New Delhi, India
        • 1160.46.91014 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.46.91001 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1160.46.91004 Boehringer Ingelheim Investigational Site
      • Tamil Nadu, India
        • 1160.46.91011 Boehringer Ingelheim Investigational Site
      • Vadodara, India
        • 1160.46.91013 Boehringer Ingelheim Investigational Site
      • Vadodra, India
        • 1160.46.91003 Boehringer Ingelheim Investigational Site
  • Israel
      • Afula, Israel
        • 1160.46.97202 Boehringer Ingelheim Investigational Site
      • Ashkelon, Israel
        • 1160.46.97207 Boehringer Ingelheim Investigational Site
      • DN Lower Galillee, Israel
        • 1160.46.97212 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1160.46.97211 Boehringer Ingelheim Investigational Site
      • Holon, Israel
        • 1160.46.97203 Boehringer Ingelheim Investigational Site
      • KfarSaba, Israel
        • 1160.46.97205 Boehringer Ingelheim Investigational Site
      • Nazareth, Israel
        • 1160.46.97209 Boehringer Ingelheim Investigational Site
      • Petah Tiqwa, Israel
        • 1160.46.97206 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1160.46.97210 Boehringer Ingelheim Investigational Site
      • Tel Hashomer, Ramat Gan, Israel
        • 1160.46.97204 Boehringer Ingelheim Investigational Site
      • Zerifin, Israel
        • 1160.46.97201 Boehringer Ingelheim Investigational Site
  • Italia
      • Catania, Italia
        • 1160.46.39011 Boehringer Ingelheim Investigational Site
      • Firenze, Italia
        • 1160.46.39015 Boehringer Ingelheim Investigational Site
      • Palermo, Italia
        • 1160.46.39012 Boehringer Ingelheim Investigational Site
      • Reggio Emilia, Italia
        • 1160.46.39007 Boehringer Ingelheim Investigational Site
      • Verona, Italia
        • 1160.46.39013 Boehringer Ingelheim Investigational Site
      • Vittorio Veneto (TV), Italia
        • 1160.46.39005 Boehringer Ingelheim Investigational Site
  • Malasia
      • Kelantan Kota Bahru, Malasia
        • 1160.46.60001 Boehringer Ingelheim Investigational Site
      • Melaka, Malasia
        • 1160.46.60003 Boehringer Ingelheim Investigational Site
      • Pahang, Malasia
        • 1160.46.60004 Boehringer Ingelheim Investigational Site
      • Selangor, Malasia
        • 1160.46.60002 Boehringer Ingelheim Investigational Site
  • Noruega
      • Oslo, Noruega
        • 1160.46.47001 Boehringer Ingelheim Investigational Site
      • Trondheim, Noruega
        • 1160.46.47005 Boehringer Ingelheim Investigational Site
  • Nueva Zelanda
      • Christchurch, Nueva Zelanda
        • 1160.46.64004 Boehringer Ingelheim Investigational Site
      • Grafton Auckland, Nueva Zelanda
        • 1160.46.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu Auckland, Nueva Zelanda
        • 1160.46.64002 Boehringer Ingelheim Investigational Site
      • Takapuna Auckland, Nueva Zelanda
        • 1160.46.64001 Boehringer Ingelheim Investigational Site
  • Pavo
      • Ankara, Pavo
        • 1160.46.90003 Boehringer Ingelheim Investigational Site
      • Ankara, Pavo
        • 1160.46.90004 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90001 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90007 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90008 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90009 Boehringer Ingelheim Investigational Site
      • Istanbul, Pavo
        • 1160.46.90010 Boehringer Ingelheim Investigational Site
  • Países Bajos
      • Alkmaar, Países Bajos
        • 1160.46.31017 Boehringer Ingelheim Investigational Site
      • Amersfoort, Países Bajos
        • 1160.46.31001 Boehringer Ingelheim Investigational Site
      • Den Bosch, Países Bajos
        • 1160.46.31010 Boehringer Ingelheim Investigational Site
      • Eindhoven, Países Bajos
        • 1160.46.31013 Boehringer Ingelheim Investigational Site
      • Heerlen, Países Bajos
        • 1160.46.31014 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Países Bajos
        • 1160.46.31002 Boehringer Ingelheim Investigational Site
      • Rotterdam, Países Bajos
        • 1160.46.31004 Boehringer Ingelheim Investigational Site
      • Zwolle, Países Bajos
        • 1160.46.31015 Boehringer Ingelheim Investigational Site
  • Polonia
      • Kielce, Polonia
        • 1160.46.48004 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.46.48001 Boehringer Ingelheim Investigational Site
      • Krakow, Polonia
        • 1160.46.48005 Boehringer Ingelheim Investigational Site
      • Poznan, Polonia
        • 1160.46.48003 Boehringer Ingelheim Investigational Site
      • Warsaw, Polonia
        • 1160.46.48006 Boehringer Ingelheim Investigational Site
  • Porcelana
      • Beijing, Porcelana
        • 1160.46.86001 Boehringer Ingelheim Investigational Site
      • Beijing, Porcelana
        • 1160.46.86002 Boehringer Ingelheim Investigational Site
      • Beijing, Porcelana
        • 1160.46.86019 Boehringer Ingelheim Investigational Site
      • Guangzhou, Porcelana
        • 1160.46.86014 Boehringer Ingelheim Investigational Site
      • Guangzhou, Porcelana
        • 1160.46.86015 Boehringer Ingelheim Investigational Site
      • Hangzhou, Porcelana
        • 1160.46.86016 Boehringer Ingelheim Investigational Site
      • Shanghai, Porcelana
        • 1160.46.86003 Boehringer Ingelheim Investigational Site
      • Shanghai, Porcelana
        • 1160.46.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, Porcelana
        • 1160.46.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, Porcelana
        • 1160.46.86011 Boehringer Ingelheim Investigational Site
      • Shenyang, Porcelana
        • 1160.46.86007 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, Porcelana
        • 1160.46.86017 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, Porcelana
        • 1160.46.86018 Boehringer Ingelheim Investigational Site
      • Taiyuan, Porcelana
        • 1160.46.86021 Boehringer Ingelheim Investigational Site
      • Tianjin, Porcelana
        • 1160.46.86006 Boehringer Ingelheim Investigational Site
      • Yinchuan, Porcelana
        • 1160.46.86020 Boehringer Ingelheim Investigational Site
  • Reino Unido
      • Headington, Oxford, Reino Unido
        • 1160.46.44005 Boehringer Ingelheim Investigational Site
      • London, Reino Unido
        • 1160.46.44011 Boehringer Ingelheim Investigational Site
      • Newcastle upon Tyne, Reino Unido
        • 1160.46.44006 Boehringer Ingelheim Investigational Site
      • Plymouth, Reino Unido
        • 1160.46.44013 Boehringer Ingelheim Investigational Site
      • Sheffield, Reino Unido
        • 1160.46.44012 Boehringer Ingelheim Investigational Site
  • República Checa
      • Brno, República Checa
        • 1160.46.42001 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, República Checa
        • 1160.46.42002 Boehringer Ingelheim Investigational Site
      • Liberec, República Checa
        • 1160.46.42012 Boehringer Ingelheim Investigational Site
      • Litomerice, República Checa
        • 1160.46.42018 Boehringer Ingelheim Investigational Site
      • Novy Jicin, República Checa
        • 1160.46.42015 Boehringer Ingelheim Investigational Site
      • Ostrava-Vitkovice, República Checa
        • 1160.46.42005 Boehringer Ingelheim Investigational Site
      • Prague 4, República Checa
        • 1160.46.42017 Boehringer Ingelheim Investigational Site
      • Tabor, República Checa
        • 1160.46.42014 Boehringer Ingelheim Investigational Site
      • Teplice, República Checa
        • 1160.46.42016 Boehringer Ingelheim Investigational Site
      • Usti nad Labem, República Checa
        • 1160.46.42010 Boehringer Ingelheim Investigational Site
      • Zlin, República Checa
        • 1160.46.42007 Boehringer Ingelheim Investigational Site
  • Singapur
      • Singapore, Singapur
        • 1160.46.65001 Boehringer Ingelheim Investigational Site
      • Singapore, Singapur
        • 1160.46.65002 Boehringer Ingelheim Investigational Site
      • Singapore, Singapur
        • 1160.46.65003 Boehringer Ingelheim Investigational Site
  • Sudáfrica
      • Bryanston, Sudáfrica
        • 1160.46.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, Sudáfrica
        • 1160.46.27013 Boehringer Ingelheim Investigational Site
      • Centurion, Sudáfrica
        • 1160.46.27007 Boehringer Ingelheim Investigational Site
      • Kempton Park, Sudáfrica
        • 1160.46.27014 Boehringer Ingelheim Investigational Site
      • Krugersdorp, Sudáfrica
        • 1160.46.27015 Boehringer Ingelheim Investigational Site
      • Morningside, Sudáfrica
        • 1160.46.27002 Boehringer Ingelheim Investigational Site
      • Plumstead, Sudáfrica
        • 1160.46.27012 Boehringer Ingelheim Investigational Site
      • Sunninghill, Sudáfrica
        • 1160.46.27006 Boehringer Ingelheim Investigational Site
  • Suecia
      • Göteborg, Suecia
        • 1160.46.46002 Boehringer Ingelheim Investigational Site
      • Kristianstad, Suecia
        • 1160.46.46010 Boehringer Ingelheim Investigational Site
      • Stockholm, Suecia
        • 1160.46.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Suecia
        • 1160.46.46008 Boehringer Ingelheim Investigational Site
      • Uppsala, Suecia
        • 1160.46.46003 Boehringer Ingelheim Investigational Site
  • Tailandia
      • Bangkok, Tailandia
        • 1160.46.66007 Boehringer Ingelheim Investigational Site
      • Bangkok, Tailandia
        • 1160.46.66010 Boehringer Ingelheim Investigational Site
      • Khon Kaen, Tailandia
        • 1160.46.66001 Boehringer Ingelheim Investigational Site
      • Muang Nakhonratchasima, Tailandia
        • 1160.46.66004 Boehringer Ingelheim Investigational Site
      • Nakhonratchasima, Tailandia
        • 1160.46.66005 Boehringer Ingelheim Investigational Site
      • Nokorn Nayok, Tailandia
        • 1160.46.66006 Boehringer Ingelheim Investigational Site
      • Phayathai, Tailandia
        • 1160.46.66008 Boehringer Ingelheim Investigational Site
  • Taiwán
      • ChangHua, Taiwán
        • 1160.46.88607 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwán
        • 1160.46.88604 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwán
        • 1160.46.88606 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwán
        • 1160.46.88608 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwán
        • 1160.46.88609 Boehringer Ingelheim Investigational Site
  • Ucrania
      • Vinnitsa, Ucrania
        • 1160.46.38005 Boehringer Ingelheim Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
  • Male or female, being 18 years of age or older
  • Written informed consent for study participation

Exclusion criteria:

  • Persistent symptoms of VTE
  • PE requiring urgent intervention
  • Use of vena cava filter
  • Contraindications to anticoagulant therapy
  • Allergy to study medications
  • Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
  • Severe renal impairment
  • Patients considered unsuitable for inclusion

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Droga: Dabigatran etexilate
150mg bid
Comparador activo: Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Droga: Warfarin
PRN (to maintain a target INR of 2.0-3.0)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de participantes con tromboembolismo venoso (TEV) sintomático recurrente y muertes relacionadas con TEV
Periodo de tiempo: Para el análisis estadístico 1: desde la aleatorización hasta el final del período posterior al tratamiento (ptp), previsto hasta el día 224. Para el análisis estadístico 2: desde la aleatorización hasta los 6 meses (hasta el día 180)
Todos los TEV recurrentes sospechados y todas las muertes y eventos hemorrágicos fueron evaluados por un comité de adjudicación central independiente, y todos los análisis se basan en los eventos que fueron confirmados centralmente por este comité.
Para el análisis estadístico 1: desde la aleatorización hasta el final del período posterior al tratamiento (ptp), previsto hasta el día 224. Para el análisis estadístico 2: desde la aleatorización hasta los 6 meses (hasta el día 180)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Recurrent Symptomatic VTE and All Deaths
Periodo de tiempo: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Recurrent Symptomatic DVT
Periodo de tiempo: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Recurrent Symptomatic Non-fatal PE
Periodo de tiempo: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants Who Died Due to VTE
Periodo de tiempo: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Number of Participants Who Died (Any Cause)
Periodo de tiempo: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Periodo de tiempo: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Periodo de tiempo: From first intake of study drug to last intake of study drug + 6 days washout

Major bleeding events (MBE) are defined as

  • 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

Clinically-relevant bleeding events (CRBE) are defined as

  • spontaneous skin hematoma >=25 cm²
  • wound hematoma >=100 cm²
  • spontaneous nose bleed >5 min
  • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
  • spontaneous rectal bleeding
  • gingival bleeding >5 min
  • leading to hospitalisation and / or requiring surgical treatment
  • leading to a transfusion of <2 units of whole blood or red cells
  • any other bleeding event considered clinically relevant by the investigator

Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
From first intake of study drug to last intake of study drug + 6 days washout
Number of Participants With Acute Coronary Syndrome (ACS)
Periodo de tiempo: From first intake of study drug to last contact date
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
From first intake of study drug to last contact date
Laboratory Analyses
Periodo de tiempo: From first intake of study drug to last intake of study drug + 6 days washout
Frequency of patients with possible clinically significant abnormalities.
From first intake of study drug to last intake of study drug + 6 days washout

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2008

Finalización primaria (Actual)

1 de mayo de 2011

Fechas de registro del estudio

Enviado por primera vez

16 de mayo de 2008

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2008

Publicado por primera vez (Estimar)

20 de mayo de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2014

Última verificación

1 de diciembre de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1160.46
  • 2007-002631-86 (Número EudraCT: EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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