Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

NCT00680186 | Completed Phase 3 Results

• 2 other identifiers: 1160.462007-002631-86
• Study Type: interventional
• Target: 2,589
• Locations: 31 countries
• Sites: 220

Brief Summary

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.

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE

  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 Outcomes (9)

• Number of Participants With Recurrent Symptomatic VTE and All Deaths

  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

  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

  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

  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)

  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.

Study Arms (2)

Dabigatran etexilate (150mg bid)

EXPERIMENTAL

Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily

Drug: Dabigatran etexilate

Warfarin (INR 2.0-3.0)

ACTIVE COMPARATOR

Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

Drug: Warfarin

Interventions

Warfarin DRUG

PRN (to maintain a target INR of 2.0-3.0)

Warfarin (INR 2.0-3.0)

Dabigatran etexilate DRUG

150mg bid

Dabigatran etexilate (150mg bid)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (220)

1160.46.01073 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

1160.46.01044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1160.46.01068 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Location

1160.46.01071 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1160.46.01060 Boehringer Ingelheim Investigational Site

Stony Brook, New York, United States

Location

1160.46.01061 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1160.46.01059 Boehringer Ingelheim Investigational Site

Bend, Oregon, United States

Location

1160.46.01063 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Location

1160.46.01055 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

Location

1160.46.01062 Boehringer Ingelheim Investigational Site

Bellevue, Washington, United States

Location

1160.46.61007 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Location

1160.46.61003 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1160.46.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1160.46.61006 Boehringer Ingelheim Investigational Site

Windsor, Victoria, Australia

Location

1160.46.61005 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Location

1160.46.55010 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1160.46.55007 Boehringer Ingelheim Investigational Site

Campinas, Brazil

Location

1160.46.55014 Boehringer Ingelheim Investigational Site

Curitiba, Brazil

Location

1160.46.55017 Boehringer Ingelheim Investigational Site

Curitiba, Brazil

Location

1160.46.55019 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1160.46.55021 Boehringer Ingelheim Investigational Site

Recife, Brazil

Location

1160.46.55016 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, Brazil

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1160.46.55018 Boehringer Ingelheim Investigational Site

São Bernardo do Campo, Brazil

Location

1160.46.55020 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1160.46.35901 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.46.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.46.35906 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.46.35905 Boehringer Ingelheim Investigational Site

Varna, Bulgaria

Location

1160.46.02006 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.46.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.46.02021 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1160.46.02004 Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

Location

1160.46.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1160.46.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.46.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.46.02010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.46.02015 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1160.46.02019 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1160.46.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.46.02009 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.46.02014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.46.02017 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.46.02020 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1160.46.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.46.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.46.86019 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.46.86014 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.46.86015 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.46.86016 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1160.46.86003 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.46.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.46.86005 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.46.86011 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.46.86007 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

1160.46.86017 Boehringer Ingelheim Investigational Site

Shijiazhuang, China

Location

1160.46.86018 Boehringer Ingelheim Investigational Site

Shijiazhuang, China

Location

1160.46.86021 Boehringer Ingelheim Investigational Site

Taiyuan, China

Location

1160.46.86006 Boehringer Ingelheim Investigational Site

Tianjin, China

Location

1160.46.86020 Boehringer Ingelheim Investigational Site

Yinchuan, China

Location

1160.46.42001 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1160.46.42002 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

1160.46.42012 Boehringer Ingelheim Investigational Site

Liberec, Czechia

Location

1160.46.42018 Boehringer Ingelheim Investigational Site

Litoměřice, Czechia

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1160.46.42015 Boehringer Ingelheim Investigational Site

Nový Jičín, Czechia

Location

1160.46.42005 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, Czechia

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1160.46.42017 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.46.42014 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1160.46.42016 Boehringer Ingelheim Investigational Site

Teplice, Czechia

Location

1160.46.42010 Boehringer Ingelheim Investigational Site

Ústí nad Labem, Czechia

Location

1160.46.42007 Boehringer Ingelheim Investigational Site

Zlín, Czechia

Location

1160.46.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1160.46.45008 Boehringer Ingelheim Investigational Site

Esbjerg, Denmark

Location

1160.46.45009 Boehringer Ingelheim Investigational Site

Holbæk, Denmark

Location

1160.46.45004 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1160.46.3301A Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.46.3301B Boehringer Ingelheim Investigational Site

Brest, France

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1160.46.3315A Boehringer Ingelheim Investigational Site

La Roche-sur-Yon, France

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1160.46.3315B Boehringer Ingelheim Investigational Site

La Roche-sur-Yon, France

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1160.46.3313A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1160.46.3316A Boehringer Ingelheim Investigational Site

Pessac, France

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1160.46.3316B Boehringer Ingelheim Investigational Site

Pessac, France

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1160.46.3303C Boehringer Ingelheim Investigational Site

Saint-Etienne, France

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1160.46.3303D Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.46.3303E Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.46.3303F Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.46.3303G Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.46.3303H Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.46.3303A Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

Location

1160.46.3303B Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

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1160.46.36002 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1160.46.36010 Boehringer Ingelheim Investigational Site

Székesfehérvár, Hungary

Location

1160.46.36011 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1160.46.91006 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1160.46.91010 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1160.46.91002 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.46.91007 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.46.91012 Boehringer Ingelheim Investigational Site

Kolkata, India

Location

1160.46.91009 Boehringer Ingelheim Investigational Site

Ludhiana, India

Location

1160.46.91008 Boehringer Ingelheim Investigational Site

Nagpur, India

Location

1160.46.91005 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.46.91014 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.46.91001 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.46.91004 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.46.91011 Boehringer Ingelheim Investigational Site

Tamil Nadu, India

Location

1160.46.91013 Boehringer Ingelheim Investigational Site

Vadodara, India

Location

1160.46.91003 Boehringer Ingelheim Investigational Site

Vadodra, India

Location

1160.46.97202 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1160.46.97207 Boehringer Ingelheim Investigational Site

Ashkelon, Israel

Location

1160.46.97212 Boehringer Ingelheim Investigational Site

DN Lower Galillee, Israel

Location

1160.46.97211 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1160.46.97203 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1160.46.97205 Boehringer Ingelheim Investigational Site

KfarSaba, Israel

Location

1160.46.97209 Boehringer Ingelheim Investigational Site

Nazareth, Israel

Location

1160.46.97206 Boehringer Ingelheim Investigational Site

Petah Tikva, Israel

Location

1160.46.97210 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1160.46.97204 Boehringer Ingelheim Investigational Site

Tel Hashomer, Ramat Gan, Israel

Location

1160.46.97201 Boehringer Ingelheim Investigational Site

Ẕerifin, Israel

Location

1160.46.39011 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

1160.46.39015 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1160.46.39012 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1160.46.39007 Boehringer Ingelheim Investigational Site

Reggio Emilia, Italy

Location

1160.46.39013 Boehringer Ingelheim Investigational Site

Verona, Italy

Location

1160.46.39005 Boehringer Ingelheim Investigational Site

Vittorio Veneto (TV), Italy

Location

1160.46.60001 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, Malaysia

Location

1160.46.60004 Boehringer Ingelheim Investigational Site

Kuala Pahang, Malaysia

Location

1160.46.60002 Boehringer Ingelheim Investigational Site

Kuala Selangor, Malaysia

Location

1160.46.60003 Boehringer Ingelheim Investigational Site

Malacca, Malaysia

Location

1160.46.31010 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1160.46.31017 Boehringer Ingelheim Investigational Site

Alkmaar, Netherlands

Location

1160.46.31001 Boehringer Ingelheim Investigational Site

Amersfoort, Netherlands

Location

1160.46.31013 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1160.46.31014 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1160.46.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, Netherlands

Location

1160.46.31004 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.46.31015 Boehringer Ingelheim Investigational Site

Zwolle, Netherlands

Location

1160.46.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1160.46.64003 Boehringer Ingelheim Investigational Site

Grafton Auckland, New Zealand

Location

1160.46.64002 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, New Zealand

Location

1160.46.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland, New Zealand

Location

1160.46.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.46.47005 Boehringer Ingelheim Investigational Site

Trondheim, Norway

Location

1160.46.63005 Boehringer Ingelheim Investigational Site

City of Muntinlupa, Philippines

Location

1160.46.63001 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1160.46.63003 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1160.46.63004 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1160.46.48004 Boehringer Ingelheim Investigational Site

Kielce, Poland

Location

1160.46.48001 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.46.48005 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.46.48003 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1160.46.48006 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.46.07021 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1160.46.07016 Boehringer Ingelheim Investigational Site

Krasnodar, Russia

Location

1160.46.07004 Boehringer Ingelheim Investigational Site

Kursk, Russia

Location

1160.46.07009 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.46.07024 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.46.07014 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1160.46.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.46.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.46.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1160.46.65001 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

1160.46.65002 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

1160.46.65003 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

1160.46.42107 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1160.46.42106 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

1160.46.42102 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1160.46.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, Slovakia

Location

1160.46.27001 Boehringer Ingelheim Investigational Site

Bryanston, South Africa

Location

1160.46.27013 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1160.46.27007 Boehringer Ingelheim Investigational Site

Centurion, South Africa

Location

1160.46.27014 Boehringer Ingelheim Investigational Site

Kempton Park, South Africa

Location

1160.46.27015 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

1160.46.27002 Boehringer Ingelheim Investigational Site

Morningside, South Africa

Location

1160.46.27012 Boehringer Ingelheim Investigational Site

Plumstead, South Africa

Location

1160.46.27006 Boehringer Ingelheim Investigational Site

Sunninghill, South Africa

Location

1160.46.82007 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1160.46.82003 Boehringer Ingelheim Investigational Site

Goyang-si, South Korea

Location

1160.46.82008 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

Location

1160.46.82010 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

Location

1160.46.82002 Boehringer Ingelheim Investigational Site

Kyunggi-do, South Korea

Location

1160.46.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.46.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.46.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.46.82009 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1160.46.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.46.34007 Boehringer Ingelheim Investigational Site

Cartagena. Murcia, Spain

Location

1160.46.34009 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.46.34015 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

1160.46.34014 Boehringer Ingelheim Investigational Site

Sabadell - Barcelona, Spain

Location

1160.46.34011 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.46.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.46.46010 Boehringer Ingelheim Investigational Site

Kristianstad, Sweden

Location

1160.46.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.46.46008 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.46.46003 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1160.46.88607 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1160.46.88604 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1160.46.88606 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1160.46.88608 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1160.46.88609 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1160.46.66007 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1160.46.66010 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1160.46.66001 Boehringer Ingelheim Investigational Site

Khon Kaen, Thailand

Location

1160.46.66004 Boehringer Ingelheim Investigational Site

Muang Nakhonratchasima, Thailand

Location

1160.46.66005 Boehringer Ingelheim Investigational Site

Nakhonratchasima, Thailand

Location

1160.46.66006 Boehringer Ingelheim Investigational Site

Nokorn Nayok, Thailand

Location

1160.46.66008 Boehringer Ingelheim Investigational Site

Phayathai, Thailand

Location

1160.46.90003 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.46.90004 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.46.90001 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.90002 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.90007 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.90008 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.90009 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.90010 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.46.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1160.46.44005 Boehringer Ingelheim Investigational Site

Headington, Oxford, United Kingdom

Location

1160.46.44011 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.46.44006 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1160.46.44013 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

1160.46.44012 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

Related Publications (3)

• Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.

  PMID: 27807306 DERIVED

• Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

  PMID: 24344086 DERIVED

• 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

MeSH Terms

Conditions

Thromboembolism

Interventions

Warfarin; Dabigatran

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: May 19, 2014
• Results First Posted: June 14, 2012

Record last verified: 2013-12

Locations

PH (4); MY (4); SE (5); RU (9); CZ (11); GB (5); IN (14); DK (4); PL (5); CA (15); US (10); SG (3); UA (1); TU (8); BR (9); KR (9); BU (4); NZ (4); TW (5); FR (15); SL (4); IL (11); ZA (8); NO (2); ES (6); TH (7); AU (5); HU (3); IT (6); NL (8); CN (16)