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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: dabigatran etexilate 150 mg twice daily (BID) (Drug); matching placebo twice daily (BID) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

Summary

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Clinical Details

Official title: Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period

Secondary outcome:

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period

Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period

Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period

Centrally Confirmed Unexplained Deaths During the Intended Treatment Period

Centrally Confirmed Bleeding Event During the Treatment Period

Centrally Confirmed Cardiovascular Events During the Treatment Period

Laboratory Measures, Especially Liver Function Tests (LFTs)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e. g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study. 2. Written informed consent Exclusion criteria: 1. Younger then 18 years of age 2. Indication for VKA other than DVT and/or PE 3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued 4. Active liver disease or liver disease decreasing survival (e. g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN 5. Creatinine clearance < 30 ml/min 6. Acute bacterial endocarditis 7. Active bleeding or high risk for bleeding. 8. Uncontrolled hypertension (investigators judgement) 9. Intake of another experimental drug within the 30 days prior to randomization into the study 10. Life expectancy <6 months 11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

Locations and Contacts

1160.63.43005 Boehringer Ingelheim Investigational Site, Graz, Austria

1160.63.43006 Boehringer Ingelheim Investigational Site, Innsbruck, Austria

1160.63.43001 Boehringer Ingelheim Investigational Site, Wien, Austria

1160.63.43002 Boehringer Ingelheim Investigational Site, Wien, Austria

1160.63.43004 Boehringer Ingelheim Investigational Site, Wien, Austria

1160.63.32005 Boehringer Ingelheim Investigational Site, Aalst, Belgium

1160.63.32004 Boehringer Ingelheim Investigational Site, Duffel, Belgium

1160.63.32003 Boehringer Ingelheim Investigational Site, Kortrijk, Belgium

1160.63.32001 Boehringer Ingelheim Investigational Site, Leuven, Belgium

1160.63.32002 Boehringer Ingelheim Investigational Site, Lier, Belgium

1160.63.02020 Boehringer Ingelheim Investigational Site, Quebec, Canada

1160.63.42004 Boehringer Ingelheim Investigational Site, Ceske Budejovice, Czech Republic

1160.63.42003 Boehringer Ingelheim Investigational Site, Jablonec nad Nisou, Czech Republic

1160.63.42008 Boehringer Ingelheim Investigational Site, Kladno, Czech Republic

1160.63.42012 Boehringer Ingelheim Investigational Site, Liberec, Czech Republic

1160.63.42010 Boehringer Ingelheim Investigational Site, Nymburk, Czech Republic

1160.63.42011 Boehringer Ingelheim Investigational Site, Ostrava-Vitkovice, Czech Republic

1160.63.42009 Boehringer Ingelheim Investigational Site, Ostrava, Czech Republic

1160.63.42002 Boehringer Ingelheim Investigational Site, Prague 4-Krc, Czech Republic

1160.63.42001 Boehringer Ingelheim Investigational Site, Prague 4, Czech Republic

1160.63.42006 Boehringer Ingelheim Investigational Site, Praha 4, Czech Republic

1160.63.42005 Boehringer Ingelheim Investigational Site, Prostejov, Czech Republic

1160.63.42007 Boehringer Ingelheim Investigational Site, Rakovnik, Czech Republic

1160.63.42013 Boehringer Ingelheim Investigational Site, Slany, Czech Republic

1160.63.42014 Boehringer Ingelheim Investigational Site, Tabor, Czech Republic

1160.63.37202 Boehringer Ingelheim Investigational Site, Kohtla-Järve, Estonia

1160.63.37203 Boehringer Ingelheim Investigational Site, Tallin, Estonia

1160.63.37201 Boehringer Ingelheim Investigational Site, Tartu, Estonia

1160.63.49013 Boehringer Ingelheim Investigational Site, Darmstadt, Germany

1160.63.49017 Boehringer Ingelheim Investigational Site, Dresden, Germany

1160.63.49018 Boehringer Ingelheim Investigational Site, Dresden, Germany

1160.63.49014 Boehringer Ingelheim Investigational Site, Gießen, Germany

1160.63.49011 Boehringer Ingelheim Investigational Site, Ludwigshafen, Germany

1160.63.49005 Boehringer Ingelheim Investigational Site, Mannheim, Germany

1160.63.49010 Boehringer Ingelheim Investigational Site, Mannheim, Germany

1160.63.49007 Boehringer Ingelheim Investigational Site, München, Germany

1160.63.49009 Boehringer Ingelheim Investigational Site, Püttlingen, Germany

1160.63.39006 Boehringer Ingelheim Investigational Site, Bergamo, Italy

1160.63.39015 Boehringer Ingelheim Investigational Site, Castelfranco Veneto (TV), Italy

1160.63.39019 Boehringer Ingelheim Investigational Site, Chieti Scalo (CH), Italy

1160.63.39003 Boehringer Ingelheim Investigational Site, Cosenza, Italy

1160.63.39008 Boehringer Ingelheim Investigational Site, Fidenza (PR), Italy

1160.63.39011 Boehringer Ingelheim Investigational Site, Firenze, Italy

1160.63.39009 Boehringer Ingelheim Investigational Site, Genova, Italy

1160.63.39004 Boehringer Ingelheim Investigational Site, Milano, Italy

1160.63.39010 Boehringer Ingelheim Investigational Site, Milano, Italy

1160.63.39020 Boehringer Ingelheim Investigational Site, Milano, Italy

1160.63.39022 Boehringer Ingelheim Investigational Site, Napoli, Italy

1160.63.39001 Boehringer Ingelheim Investigational Site, Palermo, Italy

1160.63.39007 Boehringer Ingelheim Investigational Site, Pisa, Italy

1160.63.39012 Boehringer Ingelheim Investigational Site, Rimini, Italy

1160.63.39017 Boehringer Ingelheim Investigational Site, Roma, Italy

1160.63.39014 Boehringer Ingelheim Investigational Site, Treviso, Italy

1160.63.39002 Boehringer Ingelheim Investigational Site, Udine, Italy

1160.63.39016 Boehringer Ingelheim Investigational Site, Vittorio veneto (TV), Italy

1160.63.82010 Boehringer Ingelheim Investigational Site, Gwangju-si, Korea, Republic of

1160.63.82003 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of

1160.63.82005 Boehringer Ingelheim Investigational Site, Kyeonggi-do, Korea, Republic of

1160.63.82001 Boehringer Ingelheim Investigational Site, Kyunggi-do, Korea, Republic of

1160.63.82004 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1160.63.82006 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1160.63.82008 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1160.63.82011 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1160.63.82007 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of

1160.63.37101 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia

1160.63.37102 Boehringer Ingelheim Investigational Site, Riga, Latvia

1160.63.37002 Boehringer Ingelheim Investigational Site, Kaunas, Lithuania

1160.63.37001 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania

1160.63.31010 Boehringer Ingelheim Investigational Site, Assen, Netherlands

1160.63.31006 Boehringer Ingelheim Investigational Site, Breda, Netherlands

1160.63.31007 Boehringer Ingelheim Investigational Site, Den Haag, Netherlands

1160.63.31011 Boehringer Ingelheim Investigational Site, Den Helder, Netherlands

1160.63.31012 Boehringer Ingelheim Investigational Site, Dirksland, Netherlands

1160.63.31003 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands

1160.63.31001 Boehringer Ingelheim Investigational Site, Groningen, Netherlands

1160.63.31009 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands

1160.63.31008 Boehringer Ingelheim Investigational Site, Oss, Netherlands

1160.63.64002 Boehringer Ingelheim Investigational Site, Christchurch, New Zealand

1160.63.48010 Boehringer Ingelheim Investigational Site, Kielce, Poland

1160.63.48003 Boehringer Ingelheim Investigational Site, Poznan, Poland

1160.63.48001 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48002 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48004 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48005 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48006 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48007 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.48008 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.63.07007 Boehringer Ingelheim Investigational Site, Ekaterinburg, Russian Federation

1160.63.07004 Boehringer Ingelheim Investigational Site, Kursk, Russian Federation

1160.63.07014 Boehringer Ingelheim Investigational Site, Ufa, Russian Federation

1160.63.07005 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation

1160.63.07006 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation

1160.63.65001 Boehringer Ingelheim Investigational Site, Singapore, Singapore

1160.63.27003 Boehringer Ingelheim Investigational Site, Cape Town, South Africa

1160.63.27007 Boehringer Ingelheim Investigational Site, Centurion, South Africa

1160.63.27009 Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa

1160.63.27001 Boehringer Ingelheim Investigational Site, Somerset West, South Africa

1160.63.46001 Boehringer Ingelheim Investigational Site, Göteborg, Sweden

1160.63.46006 Boehringer Ingelheim Investigational Site, Göteborg, Sweden

1160.63.46002 Boehringer Ingelheim Investigational Site, Lund, Sweden

1160.63.46004 Boehringer Ingelheim Investigational Site, Mölndal, Sweden

1160.63.46007 Boehringer Ingelheim Investigational Site, Skövde, Sweden

1160.63.46005 Boehringer Ingelheim Investigational Site, Stockholm, Sweden

1160.63.46003 Boehringer Ingelheim Investigational Site, Värnamo, Sweden

1160.63.41012 Boehringer Ingelheim Investigational Site, Basel, Switzerland

1160.63.41011 Boehringer Ingelheim Investigational Site, Bruderholz, Switzerland

1160.63.41003 Boehringer Ingelheim Investigational Site, Cham, Switzerland

1160.63.41001 Boehringer Ingelheim Investigational Site, Glarus, Switzerland

1160.63.41016 Boehringer Ingelheim Investigational Site, Luzern 16, Switzerland

1160.63.41014 Boehringer Ingelheim Investigational Site, Luzern, Switzerland

1160.63.41005 Boehringer Ingelheim Investigational Site, Schiers, Switzerland

1160.63.41009 Boehringer Ingelheim Investigational Site, Thun, Switzerland

1160.63.41022 Boehringer Ingelheim Investigational Site, Wetzikon, Switzerland

1160.63.41008 Boehringer Ingelheim Investigational Site, Zug, Switzerland

1160.63.41006 Boehringer Ingelheim Investigational Site, Zurich, Switzerland

1160.63.66002 Boehringer Ingelheim Investigational Site, Bangkok, Thailand

1160.63.66003 Boehringer Ingelheim Investigational Site, Bangkok, Thailand

1160.63.66004 Boehringer Ingelheim Investigational Site, Bangkok, Thailand

1160.63.66001 Boehringer Ingelheim Investigational Site, Chiang Mai, Thailand

1160.63.01025 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

1160.63.01023 Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States

1160.63.02013 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

1160.63.01002 Boehringer Ingelheim Investigational Site, Laguna Hills, California, United States

1160.63.01014 Boehringer Ingelheim Investigational Site, Colorado Springs, Colorado, United States

1160.63.01003 Boehringer Ingelheim Investigational Site, Jacksonville, Florida, United States

1160.63.01030 Boehringer Ingelheim Investigational Site, Key West, Florida, United States

1160.63.01022 Boehringer Ingelheim Investigational Site, Lafayette, Louisiana, United States

1160.63.01044 Boehringer Ingelheim Investigational Site, New Iberia, Louisiana, United States

1160.63.01017 Boehringer Ingelheim Investigational Site, Biddeford, Maine, United States

1160.63.01004 Boehringer Ingelheim Investigational Site, Salisbury, Maryland, United States

1160.63.01016 Boehringer Ingelheim Investigational Site, Worcester, Massachusetts, United States

1160.63.01037 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States

1160.63.01019 Boehringer Ingelheim Investigational Site, Missoula, Montana, United States

1160.63.02004 Boehringer Ingelheim Investigational Site, Saint John, New Brunswick, Canada

1160.63.01032 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States

1160.63.02005 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada

1160.63.01001 Boehringer Ingelheim Investigational Site, Uniontown, Pennsylvania, United States

1160.63.01024 Boehringer Ingelheim Investigational Site, Uniontown, Pennsylvania, United States

1160.63.61002 Boehringer Ingelheim Investigational Site, Greenslopes, Queensland, Australia

1160.63.61003 Boehringer Ingelheim Investigational Site, Elizabeth Vale, South Australia, Australia

1160.63.01005 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States

1160.63.01020 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States

1160.63.01011 Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States

1160.63.61001 Boehringer Ingelheim Investigational Site, Clayton, Victoria, Australia

1160.63.01007 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

1160.63.01035 Boehringer Ingelheim Investigational Site, Bellevue, Washington, United States

1160.63.61004 Boehringer Ingelheim Investigational Site, Nedlands, Western Australia, Australia

Additional Information

Starting date: November 2007
Last updated: June 17, 2014

Page last updated: August 23, 2015

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