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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. května 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

2589

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Lék: Dabigatran etexilate
150mg bid
Aktivní komparátor: Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Lék: Warfarin
PRN (to maintain a target INR of 2.0-3.0)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Počet účastníků s rekurentním symptomatickým žilním tromboembolismem (VTE) a úmrtími souvisejícími s VTE
Časové okno: Pro statistickou analýzu 1: od randomizace do konce období po léčbě (ptp), plánované do 224. dne. Pro statistickou analýzu 2: od randomizace do 6 měsíců (do 180. dne)
Všechna suspektní recidivující VTE a všechna úmrtí a krvácivé příhody byly hodnoceny nezávislou centrální posudkovou komisí a všechny analýzy jsou založeny na příhodách, které byly centrálně potvrzeny touto komisí.
Pro statistickou analýzu 1: od randomizace do konce období po léčbě (ptp), plánované do 224. dne. Pro statistickou analýzu 2: od randomizace do 6 měsíců (do 180. dne)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Recurrent Symptomatic VTE and All Deaths
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2008

Primární dokončení (Aktuální)

1. května 2011

Termíny zápisu do studia

První předloženo

16. května 2008

První předloženo, které splnilo kritéria kontroly kvality

19. května 2008

První zveřejněno (Odhad)

20. května 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

19. května 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. května 2014

Naposledy ověřeno

1. prosince 2013

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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