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

May 8, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2867

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • Belgium
      • Bruxelles, Belgium
        • 1160.47.32001 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1160.47.32002 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1160.47.32005 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1160.47.32004 Boehringer Ingelheim Investigational Site
  • Brazil
      • Brasília, Brazil
        • 1160.47.55010 Boehringer Ingelheim Investigational Site
      • Campinas - SP, Brazil
        • 1160.47.55007 Boehringer Ingelheim Investigational Site
      • Curitiba, Brazil
        • 1160.47.55014 Boehringer Ingelheim Investigational Site
      • Juvene - Paraná -, Brazil
        • 1160.47.55017 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro - RJ, Brazil
        • 1160.47.55016 Boehringer Ingelheim Investigational Site
      • São Bernardo do Campo, Brazil
        • 1160.47.55018 Boehringer Ingelheim Investigational Site
      • São José do Rio Preto, Brazil
        • 1160.47.55005 Boehringer Ingelheim Investigational Site
      • pTO aLEGRE, Brazil
        • 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
  • China
      • Beijing, China
        • 1160.47.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1160.47.86015 Boehringer Ingelheim Investigational Site
      • Chengdu, China
        • 1160.47.86014 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1160.47.86012 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1160.47.86009 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1160.47.86010 Boehringer Ingelheim Investigational Site
      • Nanjing, China
        • 1160.47.86013 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86002 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86003 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86006 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86007 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.47.86016 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 1160.47.86011 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • 1160.47.42001 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Czech Republic
        • 1160.47.42002 Boehringer Ingelheim Investigational Site
      • Hranice, Czech Republic
        • 1160.47.42011 Boehringer Ingelheim Investigational Site
      • Liberec, Czech Republic
        • 1160.47.42012 Boehringer Ingelheim Investigational Site
      • Novy Jicin, Czech Republic
        • 1160.47.42015 Boehringer Ingelheim Investigational Site
      • Ostrava-Vitkovice, Czech Republic
        • 1160.47.42005 Boehringer Ingelheim Investigational Site
      • Praha 2, Czech Republic
        • 1160.47.42004 Boehringer Ingelheim Investigational Site
      • Tabor, Czech Republic
        • 1160.47.42014 Boehringer Ingelheim Investigational Site
      • Usti nad Labem, Czech Republic
        • 1160.47.42010 Boehringer Ingelheim Investigational Site
      • Zlin, Czech Republic
        • 1160.47.42007 Boehringer Ingelheim Investigational Site
  • Denmark
      • Esbjerg, Denmark
        • 1160.47.45008 Boehringer Ingelheim Investigational Site
      • Holbæk, Denmark
        • 1160.47.45009 Boehringer Ingelheim Investigational Site
      • Kolding, Denmark
        • 1160.47.45002 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1160.47.45004 Boehringer Ingelheim Investigational Site
      • København S, Denmark
        • 1160.47.45007 Boehringer Ingelheim Investigational Site
      • Slagelse, Denmark
        • 1160.47.45006 Boehringer Ingelheim Investigational Site
  • Finland
      • Espoo, Finland
        • 1160.47.35804 Boehringer Ingelheim Investigational Site
      • Helsinki, Finland
        • 1160.47.35801 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 1160.47.35802 Boehringer Ingelheim Investigational Site
      • Kuopio, Finland
        • 1160.47.35805 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 1160.47.35803 Boehringer Ingelheim Investigational Site
  • France
      • Brest Cedex, France
        • 1160.47.3301A Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301B Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301C Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301D Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301E Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301F Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301H Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.47.3301I Boehringer Ingelheim Investigational Site
      • Lorient, France
        • 1160.47.3302A Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.47.3303A Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.47.3303B Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.47.3303C Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.47.3303D Boehringer Ingelheim Investigational Site
      • Vandoeuvre les Nancy, France
        • 1160.47.3308A Boehringer Ingelheim Investigational Site
  • Germany
      • Dresden, Germany
        • 1160.47.49017 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1160.47.49018 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1160.47.49003 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1160.47.49005 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1160.47.49006 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1160.47.49007 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1160.47.49008 Boehringer Ingelheim Investigational Site
      • Püttlingen, Germany
        • 1160.47.49009 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 1160.47.30001 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1160.47.30006 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1160.47.30007 Boehringer Ingelheim Investigational Site
      • Athens, Greece
        • 1160.47.30009 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1160.47.36001 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1160.47.36006 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1160.47.36007 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1160.47.36002 Boehringer Ingelheim Investigational Site
      • Gyula, Hungary
        • 1160.47.36012 Boehringer Ingelheim Investigational Site
      • Miskolc, Hungary
        • 1160.47.36004 Boehringer Ingelheim Investigational Site
      • Pecs, Hungary
        • 1160.47.36003 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungary
        • 1160.47.36011 Boehringer Ingelheim Investigational Site
      • Székesfehérvár, Hungary
        • 1160.47.36010 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
  • Israel
      • Afula, Israel
        • 1160.47.97202 Boehringer Ingelheim Investigational Site
      • Ashkelon, Israel
        • 1160.47.97207 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1160.47.97211 Boehringer Ingelheim Investigational Site
      • Holon, Israel
        • 1160.47.97203 Boehringer Ingelheim Investigational Site
      • Kfar Saba, Israel
        • 1160.47.97205 Boehringer Ingelheim Investigational Site
      • Petach Tikva, Israel
        • 1160.47.97206 Boehringer Ingelheim Investigational Site
      • Rehovot, Israel
        • 1160.47.97208 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1160.47.97210 Boehringer Ingelheim Investigational Site
      • Tel Hashomer, Israel
        • 1160.47.97204 Boehringer Ingelheim Investigational Site
      • Zerifin, Israel
        • 1160.47.97201 Boehringer Ingelheim Investigational Site
  • Italy
      • Bologna, Italy
        • 1160.47.39003 Boehringer Ingelheim Investigational Site
      • Cremona, Italy
        • 1160.47.39004 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 1160.47.39006 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1160.47.39008 Boehringer Ingelheim Investigational Site
      • Reggio Emilia, Italy
        • 1160.47.39007 Boehringer Ingelheim Investigational Site
      • Udine, Italy
        • 1160.47.39009 Boehringer Ingelheim Investigational Site
      • Vittorio Veneto, Italy
        • 1160.47.39005 Boehringer Ingelheim Investigational Site
  • Mexico
      • Chihuahua, Mexico
        • 1160.47.52036 Boehringer Ingelheim Investigational Site
      • Culiacan, Mexico
        • 1160.47.52039 Boehringer Ingelheim Investigational Site
      • Guadalajara, Jal., Mexico
        • 1160.47.52030 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1160.47.52027 Boehringer Ingelheim Investigational Site
      • San Luis Potosí, Mexico
        • 1160.47.52034 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amersfoort, Netherlands
        • 1160.47.31001 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 1160.47.31006 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 1160.47.31007 Boehringer Ingelheim Investigational Site
      • Den Bosch, Netherlands
        • 1160.47.31010 Boehringer Ingelheim Investigational Site
      • Heerlen, Netherlands
        • 1160.47.31014 Boehringer Ingelheim Investigational Site
      • Maastricht, Netherlands
        • 1160.47.31005 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1160.47.31004 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1160.47.31009 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1160.47.64004 Boehringer Ingelheim Investigational Site
      • Grafton, New Zealand
        • 1160.47.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, New Zealand
        • 1160.47.64002 Boehringer Ingelheim Investigational Site
      • Takapuna Auckland 9, New Zealand
        • 1160.47.64001 Boehringer Ingelheim Investigational Site
  • Norway
      • Oslo, Norway
        • 1160.47.47001 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1160.47.47004 Boehringer Ingelheim Investigational Site
      • Rud, Norway
        • 1160.47.47003 Boehringer Ingelheim Investigational Site
      • Trondheim, Norway
        • 1160.47.47005 Boehringer Ingelheim Investigational Site
  • Poland
      • Kielce, Poland
        • 1160.47.48004 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1160.47.48005 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1160.47.48007 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 1160.47.48003 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.47.48006 Boehringer Ingelheim Investigational Site
  • Portugal
      • Almada, Portugal
        • 1160.47.35104 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1160.47.35109 Boehringer Ingelheim Investigational Site
      • Covilhã, Portugal
        • 1160.47.35107 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1160.47.35101 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1160.47.35102 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1160.47.35105 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Belgorod, Russian Federation
        • 1160.47.07022 Boehringer Ingelheim Investigational Site
      • Chelyabinsk, Russian Federation
        • 1160.47.07011 Boehringer Ingelheim Investigational Site
      • Chelyabinsk, Russian Federation
        • 1160.47.07021 Boehringer Ingelheim Investigational Site
      • Ekaterinburg, Russian Federation
        • 1160.47.07007 Boehringer Ingelheim Investigational Site
      • Krasnodar, Russian Federation
        • 1160.47.07016 Boehringer Ingelheim Investigational Site
      • Kursk, Russian Federation
        • 1160.47.07004 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1160.47.07010 Boehringer Ingelheim Investigational Site
      • Omsk, Russian Federation
        • 1160.47.07020 Boehringer Ingelheim Investigational Site
      • Pskov, Russian Federation
        • 1160.47.07018 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.47.07009 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.47.07023 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.47.07024 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.47.07025 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1160.47.07001 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1160.47.07002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1160.47.07017 Boehringer Ingelheim Investigational Site
      • Tyumen, Russian Federation
        • 1160.47.07019 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1160.47.07014 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.47.07005 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.47.07006 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • 1160.47.42107 Boehringer Ingelheim Investigational Site
      • Lucenec, Slovakia
        • 1160.47.42106 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1160.47.42102 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Slovakia
        • 1160.47.42103 Boehringer Ingelheim Investigational Site
      • Zilina, Slovakia
        • 1160.47.42104 Boehringer Ingelheim Investigational Site
  • South Africa
      • Johannesburg, South Africa
        • 1160.47.27001 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 1160.47.27002 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 1160.47.27006 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1160.47.27007
      • Randburg, South Africa
        • 1160.47.27003 Boehringer Ingelheim Investigational Site
      • Roodepoort, South Africa
        • 1160.47.27005 Boehringer Ingelheim Investigational Site
  • Spain
      • Alicante, Spain
        • 1160.47.34006 Boehringer Ingelheim Investigational Site
      • Badalona (Barcelona), Spain
        • 1160.47.34012 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1160.47.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1160.47.34002 Boehringer Ingelheim Investigational Site
      • Cartagena. Murcia, Spain
        • 1160.47.34007 Boehringer Ingelheim Investigational Site
      • Cuenca, Spain
        • 1160.47.34003 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1160.47.34009 Boehringer Ingelheim Investigational Site
      • Santander, Spain
        • 1160.47.34004 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1160.47.34011 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1160.47.46002 Boehringer Ingelheim Investigational Site
      • Jönköping, Sweden
        • 1160.47.46006 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.47.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.47.46007 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.47.46008 Boehringer Ingelheim Investigational Site
      • Sundsvall, Sweden
        • 1160.47.46005 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1160.47.46003 Boehringer Ingelheim Investigational Site
  • Turkey
      • Ankara, Turkey
        • 1160.47.90003 Boehringer Ingelheim Investigational Site
      • Ankara, Turkey
        • 1160.47.90004 Boehringer Ingelheim Investigational Site
      • Ankara, Turkey
        • 1160.47.90005 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.47.90001 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.47.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.47.90007 Boehringer Ingelheim Investigational Site
      • Izmir, Turkey
        • 1160.47.90006 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkov, Ukraine
        • 1160.47.38002 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1160.47.38006 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1160.47.38005 Boehringer Ingelheim Investigational Site
      • Zaporozhye, Ukraine
        • 1160.47.38003 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Headington, Oxford, United Kingdom
        • 1160.47.44005 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1160.47.44009 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1160.47.44011 Boehringer Ingelheim Investigational Site
      • Newcastle upon Tyne, United Kingdom
        • 1160.47.44006 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 1160.47.44012 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • 1160.47.01035 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States
        • 1160.47.01056 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, United States
        • 1160.47.01044 Boehringer Ingelheim Investigational Site
    • Georgia
      • Augusta, Georgia, United States
        • 1160.47.01019 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, United States
        • 1160.47.01008 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1160.47.01014 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Roxbury Crossing, Massachusetts, United States
        • 1160.47.01018 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • 1160.47.01023 Boehringer Ingelheim Investigational Site
    • Minnesota
      • St. Louis Park, Minnesota, United States
        • 1160.47.01009 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 1160.47.01031 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1160.47.01036 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • 1160.47.01027 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 1160.47.01039 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, United States
        • 1160.47.01030 Boehringer Ingelheim Investigational Site
    • Ohio
      • Toledo, Ohio, United States
        • 1160.47.01013 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • 1160.47.01052 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Summerville, South Carolina, United States
        • 1160.47.01055 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1160.47.01017 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
Active Comparator: 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
Drug: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Recurrent VTE or VTE Death at 36 Months
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Recurrent VTE or All Cause Death at 36 Months
Time Frame: 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
Time Frame: 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
Time Frame: 36 months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
36 months
DVT at 18 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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