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

NCT00558259 | Completed Phase 3 Results

• 2 other identifiers: 1160.632007-002586-12
• Study Type: interventional
• Target: 1,353
• Locations: 20 countries
• Sites: 142

Brief 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).

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

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

  Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.

  6 months

Secondary Outcomes (7)

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

  6 months

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

  6 months

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

  6 months

• Centrally Confirmed Unexplained Deaths During the Intended Treatment Period

  6 months

• Centrally Confirmed Bleeding Event During the Treatment Period

  6 months

Study Arms (2)

dabigatran etexilate 150 mg BID

EXPERIMENTAL

Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Drug: dabigatran etexilate 150 mg twice daily (BID)

matching placebo twice daily (BID)

PLACEBO COMPARATOR

Patient to receive dabigatran extexilate matching placebo capsules twice daily

Drug: matching placebo twice daily (BID)

Interventions

dabigatran etexilate 150 mg twice daily (BID) DRUG

dabigatran etexilate capsules 150 mg BID

dabigatran etexilate 150 mg BID

matching placebo twice daily (BID) DRUG

Matching placebo BID

matching placebo twice daily (BID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent

You may not qualify if:

• Younger then 18 years of age
• Indication for VKA other than DVT and/or PE
• Patients in whom anticoagulant treatment for their index PE or DVT should be continued
• Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
• Creatinine clearance \< 30 ml/min
• Acute bacterial endocarditis
• Active bleeding or high risk for bleeding.
• Uncontrolled hypertension (investigators judgement)
• Intake of another experimental drug within the 30 days prior to randomization into the study
• Life expectancy \<6 months
• Childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (147)

1160.63.01025 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1160.63.01023 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1160.63.01002 Boehringer Ingelheim Investigational Site

Laguna Hills, California, United States

Location

1160.63.01014 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1160.63.01003 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1160.63.01030 Boehringer Ingelheim Investigational Site

Key West, Florida, United States

Location

1160.63.01022 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

1160.63.01044 Boehringer Ingelheim Investigational Site

New Iberia, Louisiana, United States

Location

1160.63.01017 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Location

1160.63.01004 Boehringer Ingelheim Investigational Site

Salisbury, Maryland, United States

Location

1160.63.01016 Boehringer Ingelheim Investigational Site

Worcester, Massachusetts, United States

Location

1160.63.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1160.63.01019 Boehringer Ingelheim Investigational Site

Missoula, Montana, United States

Location

1160.63.01032 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1160.63.01001 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1160.63.01024 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1160.63.01005 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1160.63.01020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

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1160.63.01011 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1160.63.01007 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1160.63.01035 Boehringer Ingelheim Investigational Site

Bellevue, Washington, United States

Location

1160.63.61002 Boehringer Ingelheim Investigational Site

Greenslopes, Queensland, Australia

Location

1160.63.61003 Boehringer Ingelheim Investigational Site

Elizabeth Vale, South Australia, Australia

Location

1160.63.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1160.63.61004 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Location

1160.63.43005 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1160.63.43006 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

1160.63.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.63.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.63.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.63.32005 Boehringer Ingelheim Investigational Site

Aalst, Belgium

Location

1160.63.32004 Boehringer Ingelheim Investigational Site

Duffel, Belgium

Location

1160.63.32003 Boehringer Ingelheim Investigational Site

Kortrijk, Belgium

Location

1160.63.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.63.32002 Boehringer Ingelheim Investigational Site

Lier, Belgium

Location

1160.63.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.63.02004 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

Location

1160.63.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.63.02020 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1160.63.42004 Boehringer Ingelheim Investigational Site

České Budějovice, Czechia

Location

1160.63.42003 Boehringer Ingelheim Investigational Site

Jablonec nad Nisou, Czechia

Location

1160.63.42008 Boehringer Ingelheim Investigational Site

Kladno, Czechia

Location

1160.63.42012 Boehringer Ingelheim Investigational Site

Liberec, Czechia

Location

1160.63.42010 Boehringer Ingelheim Investigational Site

Nymburk, Czechia

Location

1160.63.42009 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1160.63.42011 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, Czechia

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1160.63.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.63.42006 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.63.42002 Boehringer Ingelheim Investigational Site

Prague 4-Krc, Czechia

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1160.63.42005 Boehringer Ingelheim Investigational Site

Prostějov, Czechia

Location

1160.63.42007 Boehringer Ingelheim Investigational Site

Rakovník, Czechia

Location

1160.63.42013 Boehringer Ingelheim Investigational Site

Slaný, Czechia

Location

1160.63.42014 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1160.63.37202 Boehringer Ingelheim Investigational Site

Kohtla-Järve, Estonia

Location

1160.63.37203 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1160.63.37201 Boehringer Ingelheim Investigational Site

Tartu, Estonia

Location

1160.63.49013 Boehringer Ingelheim Investigational Site

Darmstadt, Germany

Location

1160.63.49017 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.63.49018 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.63.49014 Boehringer Ingelheim Investigational Site

Giessen, Germany

Location

1160.63.49011 Boehringer Ingelheim Investigational Site

Ludwigshafen, Germany

Location

1160.63.49005 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1160.63.49010 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1160.63.49007 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.63.49009 Boehringer Ingelheim Investigational Site

Püttlingen, Germany

Location

1160.63.39006 Boehringer Ingelheim Investigational Site

Bergamo, Italy

Location

1160.63.39015 Boehringer Ingelheim Investigational Site

Castelfranco Veneto (TV), Italy

Location

1160.63.39019 Boehringer Ingelheim Investigational Site

Chieti Scalo (CH), Italy

Location

1160.63.39003 Boehringer Ingelheim Investigational Site

Cosenza, Italy

Location

1160.63.39008 Boehringer Ingelheim Investigational Site

Fidenza (PR), Italy

Location

1160.63.39011 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1160.63.39009 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1160.63.39004 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.63.39010 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.63.39020 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.63.39022 Boehringer Ingelheim Investigational Site

Napoli, Italy

Location

1160.63.39001 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1160.63.39007 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1160.63.39012 Boehringer Ingelheim Investigational Site

Rimini, Italy

Location

1160.63.39017 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1160.63.39014 Boehringer Ingelheim Investigational Site

Treviso, Italy

Location

1160.63.39002 Boehringer Ingelheim Investigational Site

Udine, Italy

Location

1160.63.39016 Boehringer Ingelheim Investigational Site

Vittorio Veneto (TV), Italy

Location

1160.63.37101 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

1160.63.37102 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

1160.63.37002 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1160.63.37001 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1160.63.31010 Boehringer Ingelheim Investigational Site

Assen, Netherlands

Location

1160.63.31006 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1160.63.31011 Boehringer Ingelheim Investigational Site

Den Helder, Netherlands

Location

1160.63.31012 Boehringer Ingelheim Investigational Site

Dirksland, Netherlands

Location

1160.63.31003 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1160.63.31001 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1160.63.31009 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1160.63.31008 Boehringer Ingelheim Investigational Site

Oss, Netherlands

Location

1160.63.31007 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

1160.63.64002 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1160.63.48010 Boehringer Ingelheim Investigational Site

Kielce, Poland

Location

1160.63.48003 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1160.63.48001 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48002 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48004 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48005 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48006 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48007 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.48008 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.63.07004 Boehringer Ingelheim Investigational Site

Kursk, Russia

Location

1160.63.07014 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1160.63.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.63.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.63.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1160.63.65001 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

1160.63.27003 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1160.63.27007 Boehringer Ingelheim Investigational Site

Centurion, South Africa

Location

1160.63.27009 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

1160.63.27001 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

1160.63.82010 Boehringer Ingelheim Investigational Site

Gwangju, South Korea

Location

1160.63.82003 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1160.63.82005 Boehringer Ingelheim Investigational Site

Kyeonggi-do, South Korea

Location

1160.63.82001 Boehringer Ingelheim Investigational Site

Kyunggi-do, South Korea

Location

1160.63.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.63.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.63.82008 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.63.82011 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.63.82007 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1160.63.46001 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.63.46006 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.63.46002 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1160.63.46004 Boehringer Ingelheim Investigational Site

Mölndal, Sweden

Location

1160.63.46007 Boehringer Ingelheim Investigational Site

Skövde, Sweden

Location

1160.63.46005 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.63.46003 Boehringer Ingelheim Investigational Site

Värnamo, Sweden

Location

1160.63.41012 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

1160.63.41011 Boehringer Ingelheim Investigational Site

Bruderholz, Switzerland

Location

1160.63.41003 Boehringer Ingelheim Investigational Site

Cham, Switzerland

Location

1160.63.41001 Boehringer Ingelheim Investigational Site

Glarus, Switzerland

Location

1160.63.41014 Boehringer Ingelheim Investigational Site

Lucerne, Switzerland

Location

1160.63.41016 Boehringer Ingelheim Investigational Site

Lucerne, Switzerland

Location

1160.63.41005 Boehringer Ingelheim Investigational Site

Schiers, Switzerland

Location

1160.63.41009 Boehringer Ingelheim Investigational Site

Thun, Switzerland

Location

1160.63.41022 Boehringer Ingelheim Investigational Site

Wetzikon, Switzerland

Location

1160.63.41008 Boehringer Ingelheim Investigational Site

Zug, Switzerland

Location

1160.63.41006 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1160.63.66002 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1160.63.66003 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1160.63.66004 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1160.63.66001 Boehringer Ingelheim Investigational Site

Chiang Mai, Thailand

Location

Related Publications (2)

• Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

  PMID: 24081972 DERIVED

• Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

  PMID: 23425163 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2011
• Last Updated: June 27, 2014
• Results First Posted: March 2, 2012

Record last verified: 2014-02

Locations

LI (2); BE (5); RU (5); LA (2); ZA (4); PL (9); KR (9); CA (4); SE (7); DE (9); CZ (14); IT (18); SG (1); CH (11); AU (4); TH (4); NZ (1); US (21); ES (3); NL (9)