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Secondary Prevention of Venous Thrombo Embolism (VTE).

NCT ID: NCT00329238

Last Updated: 2014-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2867 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

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Detailed Description

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Conditions

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Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Dabigatran

Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

Dabigatran 150 mg BID (twice daily)

Warfarin (INR of 2.0-3.0)

Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Warfarin dosed individually to maintain INR 2.0-3.0

Interventions

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Dabigatran

Dabigatran 150 mg BID (twice daily)

Intervention Type DRUG

Warfarin

Warfarin dosed individually to maintain INR 2.0-3.0

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion\_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion Criteria

Exclusion\_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
* Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.47.01035 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1160.47.01056 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Site Status

1160.47.01044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1160.47.01019 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Site Status

1160.47.01008 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1160.47.01014 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1160.47.01018 Boehringer Ingelheim Investigational Site

Roxbury Crossing, Massachusetts, United States

Site Status

1160.47.01023 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

1160.47.01009 Boehringer Ingelheim Investigational Site

Saint Louis Park, Minnesota, United States

Site Status

1160.47.01031 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Site Status

1160.47.01036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1160.47.01027 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Site Status

1160.47.01039 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

1160.47.01030 Boehringer Ingelheim Investigational Site

Grand Forks, North Dakota, United States

Site Status

1160.47.01013 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1160.47.01052 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Site Status

1160.47.01055 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

Site Status

1160.47.01017 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1160.47.54017 Boehringer Ingelheim Investigational Site

Adrogué, , Argentina

Site Status

1160.47.54015 Boehringer Ingelheim Investigational Site

Bahía Blanca, , Argentina

Site Status

1160.47.54001 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1160.47.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1160.47.54005 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1160.47.54006 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.47.54007 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1160.47.54010 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1160.47.54016 Boehringer Ingelheim Investigational Site

La Plata, , Argentina

Site Status

1160.47.54014 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1160.47.54013 Boehringer Ingelheim Investigational Site

Quilmes, , Argentina

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1160.47.54011 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

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1160.47.54018 Boehringer Ingelheim Investigational Site

Salta, , Argentina

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1160.47.54012 Boehringer Ingelheim Investigational Site

Santa Fe, , Argentina

Site Status

1160.47.61002 Princess Alexandra Hospital

Wooloongabba, Queensland, Australia

Site Status

1160.47.61004 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

Site Status

1160.47.61003 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Site Status

1160.47.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

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1160.47.61006 Boehringer Ingelheim Investigational Site

Windsor, Victoria, Australia

Site Status

1160.47.61005 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Site Status

1160.47.43001 Boehringer Ingelheim Investigational Site

Graz, , Austria

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1160.47.43003 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

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1160.47.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.47.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1160.47.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1160.47.32002 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1160.47.32005 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

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1160.47.32004 Boehringer Ingelheim Investigational Site

Liège, , Belgium

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1160.47.55010 Boehringer Ingelheim Investigational Site

Brasília, , Brazil

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1160.47.55007 Boehringer Ingelheim Investigational Site

Campinas - SP, , Brazil

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1160.47.55014 Boehringer Ingelheim Investigational Site

Curitiba, , Brazil

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1160.47.55017 Boehringer Ingelheim Investigational Site

Juvene - Paraná -, , Brazil

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1160.47.55012 Boehringer Ingelheim Investigational Site

pTO aLEGRE, , Brazil

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1160.47.55016 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, , Brazil

Site Status

1160.47.55018 Boehringer Ingelheim Investigational Site

São Bernardo do Campo, , Brazil

Site Status

1160.47.55005 Boehringer Ingelheim Investigational Site

São José do Rio Preto, , Brazil

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1160.47.35910 Boehringer Ingelheim Investigational Site

Plovdiv, , Bulgaria

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1160.47.35908 Boehringer Ingelheim Investigational Site

Rousse, , Bulgaria

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1160.47.35901 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1160.47.35903 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1160.47.35904 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1160.47.35906 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1160.47.35907 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1160.47.35905 Boehringer Ingelheim Investigational Site

Varna, , Bulgaria

Site Status

1160.47.02006 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1160.47.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1160.47.02021 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1160.47.02004 Boehringer Ingelheim Investigational Site

Saint Johns, New Brunswick, Canada

Site Status

1160.47.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

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1160.47.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.47.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1160.47.02010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1160.47.02022 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1160.47.02015 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1160.47.02019 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1160.47.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1160.47.02009 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1160.47.02014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1160.47.02017 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1160.47.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.47.86015 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1160.47.86014 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1160.47.86012 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1160.47.86009 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1160.47.86010 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1160.47.86013 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1160.47.86002 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86003 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86004 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86005 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86006 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86007 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86016 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1160.47.86011 Boehringer Ingelheim Investigational Site

Shijiazhuang, , China

Site Status

1160.47.42001 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1160.47.42002 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

Site Status

1160.47.42011 Boehringer Ingelheim Investigational Site

Hranice, , Czechia

Site Status

1160.47.42012 Boehringer Ingelheim Investigational Site

Liberec, , Czechia

Site Status

1160.47.42015 Boehringer Ingelheim Investigational Site

Nový Jičín, , Czechia

Site Status

1160.47.42005 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, , Czechia

Site Status

1160.47.42004 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1160.47.42014 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

Site Status

1160.47.42010 Boehringer Ingelheim Investigational Site

Ústí nad Labem, , Czechia

Site Status

1160.47.42007 Boehringer Ingelheim Investigational Site

Zlín, , Czechia

Site Status

1160.47.45008 Boehringer Ingelheim Investigational Site

Esbjerg, , Denmark

Site Status

1160.47.45009 Boehringer Ingelheim Investigational Site

Holbæk, , Denmark

Site Status

1160.47.45002 Boehringer Ingelheim Investigational Site

Kolding, , Denmark

Site Status

1160.47.45004 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status

1160.47.45007 Boehringer Ingelheim Investigational Site

København S, , Denmark

Site Status

1160.47.45006 Boehringer Ingelheim Investigational Site

Slagelse, , Denmark

Site Status

1160.47.35804 Boehringer Ingelheim Investigational Site

Espoo, , Finland

Site Status

1160.47.35801 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

1160.47.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, , Finland

Site Status

1160.47.35805 Boehringer Ingelheim Investigational Site

Kuopio, , Finland

Site Status

1160.47.35803 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1160.47.3301A Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301B Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301C Boehringer Ingelheim Investigational Site

Brest, , France

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1160.47.3301D Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301E Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301F Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301H Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3301I Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1160.47.3302A Boehringer Ingelheim Investigational Site

Lorient, , France

Site Status

1160.47.3303A Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

Site Status

1160.47.3303B Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

Site Status

1160.47.3303C Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

Site Status

1160.47.3303D Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

Site Status

1160.47.3308A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1160.47.49003 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1160.47.49017 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1160.47.49018 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1160.47.49005 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

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1160.47.49006 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

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1160.47.49007 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1160.47.49008 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1160.47.49009 Boehringer Ingelheim Investigational Site

Püttlingen, , Germany

Site Status

1160.47.30001 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.47.30006 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.47.30007 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.47.30009 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.47.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1160.47.36006 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.47.36007 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1160.47.36002 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1160.47.36012 Boehringer Ingelheim Investigational Site

Gyula, , Hungary

Site Status

1160.47.36004 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

Site Status

1160.47.36003 Boehringer Ingelheim Investigational Site

Pécs, , Hungary

Site Status

1160.47.36010 Boehringer Ingelheim Investigational Site

Székesfehérvár, , Hungary

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1160.47.36011 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

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1160.47.91002 Boehringer Ingelheim Investigational Site

Ahmedabad, , India

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1160.47.91011 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1160.47.91015 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1160.47.91012 Boehringer Ingelheim Investigational Site

Chennai, , India

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1160.47.91017 Boehringer Ingelheim Investigational Site

Chennai, , India

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1160.47.91009 Boehringer Ingelheim Investigational Site

Madurai, , India

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1160.47.91007 Boehringer Ingelheim Investigational Site

Mysore, , India

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1160.47.91003 Boehringer Ingelheim Investigational Site

New Delhi, , India

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1160.47.91006 Boehringer Ingelheim Investigational Site

New Delhi, , India

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1160.47.91010 Boehringer Ingelheim Investigational Site

New Delhi, , India

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1160.47.91001 Boehringer Ingelheim Investigational Site

Pune, , India

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1160.47.91005 Boehringer Ingelheim Investigational Site

Pune, , India

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1160.47.91008 Boehringer Ingelheim Investigational Site

Pune, , India

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1160.47.91014 Boehringer Ingelheim Investigational Site

Trivandrum, , India

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1160.47.91004 Boehringer Ingelheim Investigational Site

Vadodara, , India

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1160.47.97202 Boehringer Ingelheim Investigational Site

Afula, , Israel

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1160.47.97207 Boehringer Ingelheim Investigational Site

Ashkelon, , Israel

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1160.47.97211 Boehringer Ingelheim Investigational Site

Haifa, , Israel

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1160.47.97203 Boehringer Ingelheim Investigational Site

Holon, , Israel

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1160.47.97205 Boehringer Ingelheim Investigational Site

Kfar Saba, , Israel

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1160.47.97206 Boehringer Ingelheim Investigational Site

Petah Tikva, , Israel

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1160.47.97208 Boehringer Ingelheim Investigational Site

Rehovot, , Israel

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1160.47.97210 Boehringer Ingelheim Investigational Site

Tel Aviv, , Israel

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1160.47.97204 Boehringer Ingelheim Investigational Site

Tel Litwinsky, , Israel

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1160.47.97201 Boehringer Ingelheim Investigational Site

Ẕerifin, , Israel

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1160.47.39003 Boehringer Ingelheim Investigational Site

Bologna, , Italy

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1160.47.39004 Boehringer Ingelheim Investigational Site

Cremona, , Italy

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1160.47.39006 Boehringer Ingelheim Investigational Site

Genova, , Italy

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1160.47.39008 Boehringer Ingelheim Investigational Site

Milan, , Italy

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1160.47.39007 Boehringer Ingelheim Investigational Site

Reggio Emilia, , Italy

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1160.47.39009 Boehringer Ingelheim Investigational Site

Udine, , Italy

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1160.47.39005 Boehringer Ingelheim Investigational Site

Vittorio Veneto, , Italy

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1160.47.52036 Boehringer Ingelheim Investigational Site

Chihuahua City, , Mexico

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1160.47.52039 Boehringer Ingelheim Investigational Site

Culiacán, , Mexico

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1160.47.52030 Boehringer Ingelheim Investigational Site

Guadalajara, Jal., , Mexico

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1160.47.52027 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

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1160.47.52034 Boehringer Ingelheim Investigational Site

San Luis Potosí City, , Mexico

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1160.47.31010 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

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1160.47.31001 Boehringer Ingelheim Investigational Site

Amersfoort, , Netherlands

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1160.47.31006 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1160.47.31007 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

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1160.47.31014 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

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1160.47.31005 Boehringer Ingelheim Investigational Site

Maastricht, , Netherlands

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1160.47.31004 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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1160.47.31009 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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1160.47.64004 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

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1160.47.64003 Boehringer Ingelheim Investigational Site

Grafton, , New Zealand

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1160.47.64002 Boehringer Ingelheim Investigational Site

Otahuhu, , New Zealand

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1160.47.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland 9, , New Zealand

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1160.47.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1160.47.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1160.47.47003 Boehringer Ingelheim Investigational Site

Rud, , Norway

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1160.47.47005 Boehringer Ingelheim Investigational Site

Trondheim, , Norway

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1160.47.48004 Boehringer Ingelheim Investigational Site

Kielce, , Poland

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1160.47.48005 Boehringer Ingelheim Investigational Site

Krakow, , Poland

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1160.47.48007 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.47.48003 Boehringer Ingelheim Investigational Site

Poznan, , Poland

Site Status

1160.47.48006 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.47.35104 Boehringer Ingelheim Investigational Site

Almada, , Portugal

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1160.47.35109 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1160.47.35107 Boehringer Ingelheim Investigational Site

Covilha, , Portugal

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1160.47.35101 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1160.47.35102 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1160.47.35105 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

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1160.47.07022 Boehringer Ingelheim Investigational Site

Belgorod, , Russia

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1160.47.07011 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

Site Status

1160.47.07021 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

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1160.47.07016 Boehringer Ingelheim Investigational Site

Krasnodar, , Russia

Site Status

1160.47.07004 Boehringer Ingelheim Investigational Site

Kursk, , Russia

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1160.47.07010 Boehringer Ingelheim Investigational Site

Novosibirsk, , Russia

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1160.47.07020 Boehringer Ingelheim Investigational Site

Omsk, , Russia

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1160.47.07018 Boehringer Ingelheim Investigational Site

Pskov, , Russia

Site Status

1160.47.07009 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

1160.47.07023 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

1160.47.07024 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

1160.47.07025 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

1160.47.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1160.47.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1160.47.07017 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1160.47.07019 Boehringer Ingelheim Investigational Site

Tyumen, , Russia

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1160.47.07014 Boehringer Ingelheim Investigational Site

Ufa, , Russia

Site Status

1160.47.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1160.47.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1160.47.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, , Russia

Site Status

1160.47.42107 Boehringer Ingelheim Investigational Site

Banská Bystrica, , Slovakia

Site Status

1160.47.42106 Boehringer Ingelheim Investigational Site

Lučenec, , Slovakia

Site Status

1160.47.42102 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1160.47.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, , Slovakia

Site Status

1160.47.42104 Boehringer Ingelheim Investigational Site

Žilina, , Slovakia

Site Status

1160.47.27001 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Site Status

1160.47.27002 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Site Status

1160.47.27006 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Site Status

1160.47.27007

Pretoria, , South Africa

Site Status

1160.47.27003 Boehringer Ingelheim Investigational Site

Randburg, , South Africa

Site Status

1160.47.27005 Boehringer Ingelheim Investigational Site

Roodepoort, , South Africa

Site Status

1160.47.34006 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1160.47.34012 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), , Spain

Site Status

1160.47.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.47.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.47.34007 Boehringer Ingelheim Investigational Site

Cartagena. Murcia, , Spain

Site Status

1160.47.34003 Boehringer Ingelheim Investigational Site

Cuenca, , Spain

Site Status

1160.47.34009 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.47.34004 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1160.47.34011 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1160.47.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.47.46006 Boehringer Ingelheim Investigational Site

Jönköping, , Sweden

Site Status

1160.47.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.47.46007 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.47.46008 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.47.46005 Boehringer Ingelheim Investigational Site

Sundsvall, , Sweden

Site Status

1160.47.46003 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1160.47.90003 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.47.90004 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.47.90005 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1160.47.90001 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.47.90002 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.47.90007 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1160.47.90006 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1160.47.38002 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1160.47.38006 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1160.47.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1160.47.38003 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

1160.47.44005 Boehringer Ingelheim Investigational Site

Headington, Oxford, , United Kingdom

Site Status

1160.47.44009 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.47.44011 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1160.47.44006 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

1160.47.44012 Boehringer Ingelheim Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Brazil Bulgaria Canada China Czechia Denmark Finland France Germany Greece Hungary India Israel Italy Mexico Netherlands New Zealand Norway Poland Portugal Russia Slovakia South Africa Spain Sweden Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27807306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24081972 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23425163 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-002536-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.47

Identifier Type: -

Identifier Source: org_study_id

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