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)

May 8, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2589

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

  • 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
  • Brazil
      • Brasília, Brazil
        • 1160.46.55010 Boehringer Ingelheim Investigational Site
      • Campinas, Brazil
        • 1160.46.55007 Boehringer Ingelheim Investigational Site
      • Curitiba, Brazil
        • 1160.46.55014 Boehringer Ingelheim Investigational Site
      • Curitiba, Brazil
        • 1160.46.55017 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1160.46.55019 Boehringer Ingelheim Investigational Site
      • Recife, Brazil
        • 1160.46.55021 Boehringer Ingelheim Investigational Site
      • Rio de Janeiro - RJ, Brazil
        • 1160.46.55016 Boehringer Ingelheim Investigational Site
      • São Bernardo do Campo, Brazil
        • 1160.46.55018 Boehringer Ingelheim Investigational Site
      • São Paulo, Brazil
        • 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
  • Canada
      • Quebec, Canada
        • 1160.46.02020 Boehringer Ingelheim Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada
        • 1160.46.02006 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1160.46.02013 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • 1160.46.02021 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • 1160.46.02004 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1160.46.02001 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1160.46.02002 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.46.02005 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1160.46.02010 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1160.46.02015 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1160.46.02019 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1160.46.02008 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.46.02009 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.46.02014 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1160.46.02017 Boehringer Ingelheim Investigational Site
  • China
      • Beijing, China
        • 1160.46.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1160.46.86002 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1160.46.86019 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1160.46.86014 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1160.46.86015 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1160.46.86016 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.46.86003 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.46.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.46.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1160.46.86011 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 1160.46.86007 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 1160.46.86017 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 1160.46.86018 Boehringer Ingelheim Investigational Site
      • Taiyuan, China
        • 1160.46.86021 Boehringer Ingelheim Investigational Site
      • Tianjin, China
        • 1160.46.86006 Boehringer Ingelheim Investigational Site
      • Yinchuan, China
        • 1160.46.86020 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • 1160.46.42001 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Czech Republic
        • 1160.46.42002 Boehringer Ingelheim Investigational Site
      • Liberec, Czech Republic
        • 1160.46.42012 Boehringer Ingelheim Investigational Site
      • Litomerice, Czech Republic
        • 1160.46.42018 Boehringer Ingelheim Investigational Site
      • Novy Jicin, Czech Republic
        • 1160.46.42015 Boehringer Ingelheim Investigational Site
      • Ostrava-Vitkovice, Czech Republic
        • 1160.46.42005 Boehringer Ingelheim Investigational Site
      • Prague 4, Czech Republic
        • 1160.46.42017 Boehringer Ingelheim Investigational Site
      • Tabor, Czech Republic
        • 1160.46.42014 Boehringer Ingelheim Investigational Site
      • Teplice, Czech Republic
        • 1160.46.42016 Boehringer Ingelheim Investigational Site
      • Usti nad Labem, Czech Republic
        • 1160.46.42010 Boehringer Ingelheim Investigational Site
      • Zlin, Czech Republic
        • 1160.46.42007 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aarhus C, Denmark
        • 1160.46.45001 Boehringer Ingelheim Investigational Site
      • Esbjerg, Denmark
        • 1160.46.45008 Boehringer Ingelheim Investigational Site
      • Holbæk, Denmark
        • 1160.46.45009 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1160.46.45004 Boehringer Ingelheim Investigational Site
  • France
      • Brest Cedex, France
        • 1160.46.3301A Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1160.46.3301B Boehringer Ingelheim Investigational Site
      • La Roche-Sur-Yon cedex 09, France
        • 1160.46.3315A Boehringer Ingelheim Investigational Site
      • La Roche-Sur-Yon cedex 09, France
        • 1160.46.3315B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1160.46.3313A Boehringer Ingelheim Investigational Site
      • Pessac, France
        • 1160.46.3316A Boehringer Ingelheim Investigational Site
      • Pessac, France
        • 1160.46.3316B Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303C Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303D Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303E Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303F Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303G Boehringer Ingelheim Investigational Site
      • St Etienne Cedex 2, France
        • 1160.46.3303H Boehringer Ingelheim Investigational Site
      • St Priest En Jarez Cedex, France
        • 1160.46.3303A Boehringer Ingelheim Investigational Site
      • St Priest En Jarez Cedex, France
        • 1160.46.3303B Boehringer Ingelheim Investigational Site
  • Hungary
      • Debrecen, Hungary
        • 1160.46.36002 Boehringer Ingelheim Investigational Site
      • Szekesfehervar, Hungary
        • 1160.46.36010 Boehringer Ingelheim Investigational Site
      • Szombathely, Hungary
        • 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
  • Italy
      • Catania, Italy
        • 1160.46.39011 Boehringer Ingelheim Investigational Site
      • Firenze, Italy
        • 1160.46.39015 Boehringer Ingelheim Investigational Site
      • Palermo, Italy
        • 1160.46.39012 Boehringer Ingelheim Investigational Site
      • Reggio Emilia, Italy
        • 1160.46.39007 Boehringer Ingelheim Investigational Site
      • Verona, Italy
        • 1160.46.39013 Boehringer Ingelheim Investigational Site
      • Vittorio Veneto (TV), Italy
        • 1160.46.39005 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 1160.46.82007 Boehringer Ingelheim Investigational Site
      • Goyang-si, Korea, Republic of
        • 1160.46.82003 Boehringer Ingelheim Investigational Site
      • Gyeonggi-do, Korea, Republic of
        • 1160.46.82008 Boehringer Ingelheim Investigational Site
      • Gyeonggi-do, Korea, Republic of
        • 1160.46.82010 Boehringer Ingelheim Investigational Site
      • Kyunggi-do, Korea, Republic of
        • 1160.46.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.46.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.46.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.46.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1160.46.82009 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Kelantan Kota Bahru, Malaysia
        • 1160.46.60001 Boehringer Ingelheim Investigational Site
      • Melaka, Malaysia
        • 1160.46.60003 Boehringer Ingelheim Investigational Site
      • Pahang, Malaysia
        • 1160.46.60004 Boehringer Ingelheim Investigational Site
      • Selangor, Malaysia
        • 1160.46.60002 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Alkmaar, Netherlands
        • 1160.46.31017 Boehringer Ingelheim Investigational Site
      • Amersfoort, Netherlands
        • 1160.46.31001 Boehringer Ingelheim Investigational Site
      • Den Bosch, Netherlands
        • 1160.46.31010 Boehringer Ingelheim Investigational Site
      • Eindhoven, Netherlands
        • 1160.46.31013 Boehringer Ingelheim Investigational Site
      • Heerlen, Netherlands
        • 1160.46.31014 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Netherlands
        • 1160.46.31002 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1160.46.31004 Boehringer Ingelheim Investigational Site
      • Zwolle, Netherlands
        • 1160.46.31015 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1160.46.64004 Boehringer Ingelheim Investigational Site
      • Grafton Auckland, New Zealand
        • 1160.46.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu Auckland, New Zealand
        • 1160.46.64002 Boehringer Ingelheim Investigational Site
      • Takapuna Auckland, New Zealand
        • 1160.46.64001 Boehringer Ingelheim Investigational Site
  • Norway
      • Oslo, Norway
        • 1160.46.47001 Boehringer Ingelheim Investigational Site
      • Trondheim, Norway
        • 1160.46.47005 Boehringer Ingelheim Investigational Site
  • Philippines
      • Manila, Philippines
        • 1160.46.63001 Boehringer Ingelheim Investigational Site
      • Muntinlupa, Philippines
        • 1160.46.63005 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1160.46.63003 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1160.46.63004 Boehringer Ingelheim Investigational Site
  • Poland
      • Kielce, Poland
        • 1160.46.48004 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1160.46.48001 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1160.46.48005 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 1160.46.48003 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1160.46.48006 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • 1160.46.07021 Boehringer Ingelheim Investigational Site
      • Ekaterinburg, Russian Federation
        • 1160.46.07007 Boehringer Ingelheim Investigational Site
      • Krasnodar, Russian Federation
        • 1160.46.07016 Boehringer Ingelheim Investigational Site
      • Kursk, Russian Federation
        • 1160.46.07004 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.46.07009 Boehringer Ingelheim Investigational Site
      • Rostov-na-Donu, Russian Federation
        • 1160.46.07024 Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • 1160.46.07014 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.46.07005 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1160.46.07006 Boehringer Ingelheim Investigational Site
  • Singapore
      • Singapore, Singapore
        • 1160.46.65001 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 1160.46.65002 Boehringer Ingelheim Investigational Site
      • Singapore, Singapore
        • 1160.46.65003 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • 1160.46.42107 Boehringer Ingelheim Investigational Site
      • Lucenec, Slovakia
        • 1160.46.42106 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1160.46.42102 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Slovakia
        • 1160.46.42103 Boehringer Ingelheim Investigational Site
  • South Africa
      • Bryanston, South Africa
        • 1160.46.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1160.46.27013 Boehringer Ingelheim Investigational Site
      • Centurion, South Africa
        • 1160.46.27007 Boehringer Ingelheim Investigational Site
      • Kempton Park, South Africa
        • 1160.46.27014 Boehringer Ingelheim Investigational Site
      • Krugersdorp, South Africa
        • 1160.46.27015 Boehringer Ingelheim Investigational Site
      • Morningside, South Africa
        • 1160.46.27002 Boehringer Ingelheim Investigational Site
      • Plumstead, South Africa
        • 1160.46.27012 Boehringer Ingelheim Investigational Site
      • Sunninghill, South Africa
        • 1160.46.27006 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1160.46.34002 Boehringer Ingelheim Investigational Site
      • Cartagena. Murcia, Spain
        • 1160.46.34007 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1160.46.34009 Boehringer Ingelheim Investigational Site
      • Palma de Mallorca, Spain
        • 1160.46.34015 Boehringer Ingelheim Investigational Site
      • Sabadell - barcelona, Spain
        • 1160.46.34014 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1160.46.34011 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1160.46.46002 Boehringer Ingelheim Investigational Site
      • Kristianstad, Sweden
        • 1160.46.46010 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.46.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1160.46.46008 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1160.46.46003 Boehringer Ingelheim Investigational Site
  • Taiwan
      • ChangHua, Taiwan
        • 1160.46.88607 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1160.46.88604 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1160.46.88606 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1160.46.88608 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1160.46.88609 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • 1160.46.66007 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 1160.46.66010 Boehringer Ingelheim Investigational Site
      • Khon Kaen, Thailand
        • 1160.46.66001 Boehringer Ingelheim Investigational Site
      • Muang Nakhonratchasima, Thailand
        • 1160.46.66004 Boehringer Ingelheim Investigational Site
      • Nakhonratchasima, Thailand
        • 1160.46.66005 Boehringer Ingelheim Investigational Site
      • Nokorn Nayok, Thailand
        • 1160.46.66006 Boehringer Ingelheim Investigational Site
      • Phayathai, Thailand
        • 1160.46.66008 Boehringer Ingelheim Investigational Site
  • Turkey
      • Ankara, Turkey
        • 1160.46.90003 Boehringer Ingelheim Investigational Site
      • Ankara, Turkey
        • 1160.46.90004 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90001 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90007 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90008 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90009 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1160.46.90010 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Vinnitsa, Ukraine
        • 1160.46.38005 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Headington, Oxford, United Kingdom
        • 1160.46.44005 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1160.46.44011 Boehringer Ingelheim Investigational Site
      • Newcastle upon Tyne, United Kingdom
        • 1160.46.44006 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 1160.46.44013 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 1160.46.44012 Boehringer Ingelheim Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • 1160.46.01073 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, United States
        • 1160.46.01044 Boehringer Ingelheim Investigational Site
    • Illinois
      • Normal, Illinois, United States
        • 1160.46.01068 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • 1160.46.01071 Boehringer Ingelheim Investigational Site
    • New York
      • Stony Brook, New York, United States
        • 1160.46.01060 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1160.46.01061 Boehringer Ingelheim Investigational Site
    • Oregon
      • Bend, Oregon, United States
        • 1160.46.01059 Boehringer Ingelheim Investigational Site
      • Corvallis, Oregon, United States
        • 1160.46.01063 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Summerville, South Carolina, United States
        • 1160.46.01055 Boehringer Ingelheim Investigational Site
    • Washington
      • Bellevue, Washington, United States
        • 1160.46.01062 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:

  • 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

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 etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Drug: Dabigatran etexilate
150mg bid
Active Comparator: Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Drug: Warfarin
PRN (to maintain a target INR of 2.0-3.0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
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 end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrent Symptomatic VTE and All Deaths
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

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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

April 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 20, 2008

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

  • 1160.46
  • 2007-002631-86 (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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