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Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (RE-COVER I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00291330
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : February 11, 2011
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: dabigatran etexilate 150 mg Drug: warfarin (INR 2-3) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
Study Start Date : February 2006
Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: dabigatran etexilate 150 mg
twice daily
Drug: dabigatran etexilate 150 mg
twice daily
Active Comparator: warfarin (INR 2-3)
prn to maintain INR (2-3)
Drug: warfarin (INR 2-3)
prn to maintain INR (2-3)


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE [ Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) ]
    All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.


Secondary Outcome Measures :
  1. Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    VTE or any death which occured from randomisation to end of post treatment period.

    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.


  2. Number of Participants With Recurrent Symptomatic DVT [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    Symptomatic DVT which occured from randomisation to end of post treatment period.

    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.


  3. Number of Participants With Recurrent Symptomatic Non-fatal PE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.

    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.


  4. Number of Participants Who Died Due to VTE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    VTE - related deaths which occured from randomisation to end of post treatment period.

    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.


  5. Number of Participants Who Died (Any Cause) [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]
    Any deaths which occured from randomisation to end of post treatment period. 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.

  6. Number of Participants With Bleeding Events [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug) ]

    Major bleeding events (MBE) were defined as

    • Fatal bleeding
    • Symptomatic bleeding in a critical area or organ
    • Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells

    Clinically-relevant bleeding events (CRBE) was defined as

    • spontaneous skin hematoma >=25 cm²
    • spontaneous nose bleed >5 min
    • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
    • spontaneous rectal bleeding (more than spotting on toilet paper)
    • gingival bleeding >5 min
    • leading to hospitalisation and / or requiring surgical treatment
    • leading to a transfusion of <2 units of whole blood or red cells
    • any other bleeding event considered clinically relevant by the investigator

    Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.


  7. Number of Participants With Acute Coronary Syndrome (ACS) [ Time Frame: From first intake of study drug to end of study conduct ]

    Any ACS occurring during the conduct of the study (centrally adjudicated as definite).

    Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.

    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.


  8. Laboratory Analyses [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug) ]
    Frequency of patients with possible clinically significant abnormalities.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
  2. Male or female, being 18 years of age or older
  3. Written informed consent for study participation

Exclusion criteria

  1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
  2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
  3. Actual or anticipated use of vena cava filter
  4. Contraindications to anticoagulant therapy
  5. Patients who in the investigators opinion should not be treated with warfarin
  6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
  7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
  8. Known anaemia
  9. Need of anticoagulant treatment for disorders other than VTE
  10. Recent unstable cardiovascular disease
  11. Elevated AST or ALT > 2x ULN
  12. Liver disease expected to have any potential impact on survival
  13. Patients who have developed transaminase elevations upon exposure to ximelagatran
  14. Severe renal impairment
  15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
  16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
  17. Patients considered unsuitable for inclusion by the investigator
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291330


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Locations
United States, Alabama
1160.53.01035 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
United States, Connecticut
1160.53.01056 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
United States, Florida
1160.53.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1160.53.01033 Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
1160.53.01046 Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
United States, Georgia
1160.53.01019 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States
1160.53.01008 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1160.53.01010 Boehringer Ingelheim Investigational Site
Marietta, Georgia, United States
United States, Maryland
1160.53.01014 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Michigan
1160.53.01023 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1160.53.01029 Boehringer Ingelheim Investigational Site
Pontiac, Michigan, United States
United States, Minnesota
1160.53.01009 Boehringer Ingelheim Investigational Site
St. Louis Park, Minnesota, United States
United States, New Hampshire
1160.53.01031 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, New Mexico
1160.53.01036 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
1160.53.01025 Boehringer Ingelheim Investigational Site
Valhalla, New York, United States
United States, North Carolina
1160.53.01027 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
1160.53.01039 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, North Dakota
1160.53.01030 Boehringer Ingelheim Investigational Site
Grand Forks, North Dakota, United States
United States, Ohio
1160.53.01013 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
United States, Oregon
1160.53.01028 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
1160.53.01052 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania, United States
United States, South Carolina
1160.53.01055 Boehringer Ingelheim Investigational Site
Summerville, South Carolina, United States
United States, Virginia
1160.53.01017 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Argentina
1160.53.54017 Boehringer Ingelheim Investigational Site
Adrogué, Argentina
1160.53.54003 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1160.53.54005 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1160.53.54006 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1160.53.54007 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1160.53.54010 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
Australia, Queensland
1160.53.61002 Boehringer Ingelheim Investigational Site
Woolloongabba, Queensland, Australia
Australia, South Australia
1160.53.61004 Boehringer Ingelheim Investigational Site
Bedford Park, South Australia, Australia
Australia, Victoria
1160.53.61003 Boehringer Ingelheim Investigational Site
Box Hill, Victoria, Australia
1160.53.61001 Boehringer Ingelheim Investigational Site
Clayton, Victoria, Australia
1160.53.61006 The Avenue Cardiovascular Centre
Windsor, Victoria, Australia
Australia, Western Australia
1160.53.61005 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
Austria
1160.53.43001 Boehringer Ingelheim Investigational Site
Graz, Austria
1160.53.43003 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
1160.53.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1160.53.32003 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1160.53.32001 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1160.53.32002 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1160.53.32007 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1160.53.32005 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1160.53.32004 Boehringer Ingelheim Investigational Site
Liège, Belgium
Brazil
1160.53.55010 Boehringer Ingelheim Investigational Site
Brasília, Brazil
1160.53.55007 Boehringer Ingelheim Investigational Site
Campinas, Brazil
1160.53.55001 Boehringer Ingelheim Investigational Site
Cerqueira César - Sao Paulo, Brazil
1160.53.55002 Boehringer Ingelheim Investigational Site
Cerqueira César - São Paulo, Brazil
1160.53.55014 Boehringer Ingelheim Investigational Site
Cristo Rei - Curitiba, Brazil
1160.53.55011 Boehringer Ingelheim Investigational Site
Goiânia -, Brazil
1160.53.55017 Boehringer Ingelheim Investigational Site
Paraná -, Brazil
1160.53.55012 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1160.53.55016 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ, Brazil
1160.53.55004 Boehringer Ingelheim Investigational Site
Santo André, Brazil
1160.53.55005 Boehringer Ingelheim Investigational Site
São José do Rio Preto, Brazil
Canada, Alberta
1160.53.02006 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1160.53.02013 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1160.53.02021 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, New Brunswick
1160.53.02004 Boehringer Ingelheim Investigational Site
Saint Johns, New Brunswick, Canada
Canada, Nova Scotia
1160.53.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1160.53.02002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.53.02005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.53.02010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.53.02022 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.53.02011 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1160.53.02015 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1160.53.02019 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1160.53.02008 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.53.02009 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.53.02014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.53.02017 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.53.02003 Boehringer Ingelheim Investigational Site
Sainte-Foy, Quebec, Canada
Canada
1160.53.02020 Boehringer Ingelheim Investigational Site
Quebec, Canada
Czech Republic
1160.53.42001 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1160.53.42002 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czech Republic
1160.53.42011 Boehringer Ingelheim Investigational Site
Hranice, Czech Republic
1160.53.42009 Boehringer Ingelheim Investigational Site
Jihlava, Czech Republic
1160.53.42012 Boehringer Ingelheim Investigational Site
Liberec, Czech Republic
1160.53.42015 Boehringer Ingelheim Investigational Site
Novy Jicin, Czech Republic
1160.53.42005 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice, Czech Republic
1160.53.42004 Boehringer Ingelheim Investigational Site
Praha 2, Czech Republic
1160.53.42014 Boehringer Ingelheim Investigational Site
Tabor, Czech Republic
1160.53.42016 Boehringer Ingelheim Investigational Site
Teplice, Czech Republic
1160.53.42010 Boehringer Ingelheim Investigational Site
Usti nad Labem, Czech Republic
1160.53.42007 Boehringer Ingelheim Investigational Site
Zlin, Czech Republic
Denmark
1160.53.45008 Boehringer Ingelheim Investigational Site
Esbjerg, Denmark
1160.53.45009 Boehringer Ingelheim Investigational Site
Holbæk, Denmark
1160.53.45002 Boehringer Ingelheim Investigational Site
Kolding, Denmark
1160.53.45004 Boehringer Ingelheim Investigational Site
København NV, Denmark
1160.53.45007 Boehringer Ingelheim Investigational Site
København S, Denmark
1160.53.45006 Boehringer Ingelheim Investigational Site
Slagelse, Denmark
France
1160.53.3301A Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301B Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301C Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301D Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301E Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301F Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301H Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3301I Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.53.3302A Boehringer Ingelheim Investigational Site
Lorient, France
1160.53.3310A Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
1160.53.3310B Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
1160.53.3310C Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
1160.53.3308B Boehringer Ingelheim Investigational Site
Nancy, France
1160.53.3303B Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.53.3303C Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.53.3303D Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.53.3303E Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.53.3303A Boehringer Ingelheim Investigational Site
St Priest en Jarez, France
1160.53.3311A Boehringer Ingelheim Investigational Site
Toulon Naval, France
1160.53.3311B Boehringer Ingelheim Investigational Site
Toulon Naval, France
1160.53.3311C Boehringer Ingelheim Investigational Site
Toulon Naval, France
1160.53.3311D Boehringer Ingelheim Investigational Site
Toulon Naval, France
1160.53.3311E Boehringer Ingelheim Investigational Site
Toulon Naval, France
1160.53.3308A Boehringer Ingelheim Investigational Site
Vandoeuvre les Nancy, France
Germany
1160.53.49017 Boehringer Ingelheim Investigational Site
Dresden, Germany
1160.53.49018 Boehringer Ingelheim Investigational Site
Dresden, Germany
1160.53.49003 Boehringer Ingelheim Investigational Site
Köln, Germany
1160.53.49005 Boehringer Ingelheim Investigational Site
Mannheim, Germany
1160.53.49007 Boehringer Ingelheim Investigational Site
München, Germany
1160.53.49009 Boehringer Ingelheim Investigational Site
Püttlingen, Germany
Greece
1160.53.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
1160.53.30005 Boehringer Ingelheim Investigational Site
Athens, Greece
1160.53.30006 Boehringer Ingelheim Investigational Site
Athens, Greece
Hungary
1160.53.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1160.53.36006 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1160.53.36002 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1160.53.36013 Boehringer Ingelheim Investigational Site
Eger, Hungary
1160.53.36012 Boehringer Ingelheim Investigational Site
Gyula, Hungary
1160.53.36004 Boehringer Ingelheim Investigational Site
Miskolc, Hungary
1160.53.36003 Boehringer Ingelheim Investigational Site
Pecs, Hungary
1160.53.36011 Boehringer Ingelheim Investigational Site
Szombathely, Hungary
1160.53.36010 Boehringer Ingelheim Investigational Site
Székesfehérvár, Hungary
India
1160.53.91011 Boehringer Ingelheim Investigational Site
Bangalore, India
1160.53.91012 Boehringer Ingelheim Investigational Site
Chennai, India
1160.53.91019 Boehringer Ingelheim Investigational Site
Chennai, India
1160.53.91013 Boehringer Ingelheim Investigational Site
Indore, India
1160.53.91021 Boehringer Ingelheim Investigational Site
Karna, India
1160.53.91022 Boehringer Ingelheim Investigational Site
Kerala, India
1160.53.91020 Boehringer Ingelheim Investigational Site
Ludhiana, India
1160.53.91007 Boehringer Ingelheim Investigational Site
Mysore, India
1160.53.91015 Boehringer Ingelheim Investigational Site
Nagpur, India
1160.53.91010 Boehringer Ingelheim Investigational Site
New Delhi, India
1160.53.91005 Boehringer Ingelheim Investigational Site
Pune, India
1160.53.91008 Boehringer Ingelheim Investigational Site
Pune, India
1160.53.91004 Boehringer Ingelheim Investigational Site
Vadodara, India
Israel
1160.53.97202 Boehringer Ingelheim Investigational Site
Afula, Israel
1160.53.97207 Boehringer Ingelheim Investigational Site
Ashkelon, Israel
1160.53.97211 Boehringer Ingelheim Investigational Site
Haifa, Israel
1160.53.97203 Boehringer Ingelheim Investigational Site
Holon, Israel
1160.53.97205 Boehringer Ingelheim Investigational Site
KfarSaba, Israel
1160.53.97206 Boehringer Ingelheim Investigational Site
Petah Tiqwa, Israel
1160.53.97204 Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
1160.53.97210 Boehringer Ingelheim Investigational Site
Tel-Aviv, Israel
1160.53.97201 Boehringer Ingelheim Investigational Site
Zerifin, Israel
Italy
1160.53.39003 Boehringer Ingelheim Investigational Site
Bologna, Italy
1160.53.39002 Boehringer Ingelheim Investigational Site
Padova, Italy
1160.53.39001 Boehringer Ingelheim Investigational Site
Perugia, Italy
1160.53.39004 Boehringer Ingelheim Investigational Site
Reggio Emilia, Italy
1160.53.39007 Boehringer Ingelheim Investigational Site
Vimercate, Italy
1160.53.39005 Boehringer Ingelheim Investigational Site
Vittorio Veneto (tv), Italy
Mexico
1160.53.5264 Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
1160.53.5270 Boehringer Ingelheim Investigational Site
Culiacan, Mexico
1160.53.5262 Boehringer Ingelheim Investigational Site
San Luis Potosí, Mexico
Netherlands
1160.53.31010 Boehringer Ingelheim Investigational Site
's Hertogenbosch, Netherlands
1160.53.31001 Boehringer Ingelheim Investigational Site
Amersfoort, Netherlands
1160.53.31006 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1160.53.31013 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1160.53.31005 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
1160.53.31002 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
1160.53.31004 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
1160.53.31009 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
New Zealand
1160.53.64003 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1160.53.64004 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
1160.53.64002 Boehringer Ingelheim Investigational Site
Otahuhu Auckland, New Zealand
1160.53.64001 Boehringer Ingelheim Investigational Site
Takapuna Auckland, New Zealand
Norway
1160.53.47001 Boehringer Ingelheim Investigational Site
Oslo, Norway
1160.53.47004 Boehringer Ingelheim Investigational Site
Oslo, Norway
1160.53.47003 Boehringer Ingelheim Investigational Site
Rud, Norway
1160.53.47005 Boehringer Ingelheim Investigational Site
Trondheim, Norway
Portugal
1160.53.35104 Boehringer Ingelheim Investigational Site
Almada, Portugal
1160.53.35109 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1160.53.35101 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1160.53.35102 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1160.53.35105 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
Russian Federation
1160.53.07011 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1160.53.07021 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1160.53.07007 Boehringer Ingelheim Investigational Site
Ekaterinburg, Russian Federation
1160.53.07016 Boehringer Ingelheim Investigational Site
Krasnodar, Russian Federation
1160.53.07004 Boehringer Ingelheim Investigational Site
Kursk, Russian Federation
1160.53.07003 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1160.53.07010 Boehringer Ingelheim Investigational Site
Novosibirsk, Russian Federation
1160.53.07020 Boehringer Ingelheim Investigational Site
Omsk, Russian Federation
1160.53.07018 Boehringer Ingelheim Investigational Site
Pskov, Russian Federation
1160.53.07009 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.53.07023 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.53.07024 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.53.07025 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.53.07001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1160.53.07014 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
1160.53.07005 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
1160.53.07006 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
Slovakia
1160.53.42107 Boehringer Ingelheim Investigational Site
Banska Bystrica, Slovakia
1160.53.42106 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
1160.53.42102 Boehringer Ingelheim Investigational Site
Nitra, Slovakia
1160.53.42103 Boehringer Ingelheim Investigational Site
Nove Zamky, Slovakia
1160.53.42104 Boehringer Ingelheim Investigational Site
Zilina, Slovakia
South Africa
1160.53.27007 Boehringer Ingelheim Investigational Site
Centurion, South Africa
1160.53.27001 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.53.27002 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.53.27004 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.53.27006 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.53.27009 Suite 404, Medical Centre
Pretoria, South Africa
1160.53.27003 Boehringer Ingelheim Investigational Site
Randburg, South Africa
1160.53.27008 Suite M5, Second Floor
Richards Bay, South Africa
1160.53.27005 Boehringer Ingelheim Investigational Site
Roodepoort, South Africa
Spain
1160.53.34012 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
1160.53.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.53.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.53.34007 Boehringer Ingelheim Investigational Site
Cartagena. Murcia, Spain
1160.53.34003 Boehringer Ingelheim Investigational Site
Cuenca, Spain
1160.53.34009 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.53.34010 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.53.34004 Boehringer Ingelheim Investigational Site
Santander, Spain
1160.53.34005 Boehringer Ingelheim Investigational Site
Torrelavega.Santander, Spain
1160.53.34011 Boehringer Ingelheim Investigational Site
Valencia, Spain
Sweden
1160.53.46002 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1160.53.46006 Boehringer Ingelheim Investigational Site
Jönköping, Sweden
1160.53.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.53.46007 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.53.46008 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.53.46005 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden
1160.53.46003 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Turkey
1160.53.90003 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.53.90004 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.53.90005 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.53.90001 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.53.90002 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.53.90007 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.53.90006 Boehringer Ingelheim Investigational Site
Izmir, Turkey
Ukraine
1160.53.38006 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1160.53.38005 Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
1160.53.38003 Boehringer Ingelheim Investigational Site
Zaporozhye, Ukraine
United Kingdom
1160.53.44008 Boehringer Ingelheim Investigational Site
Aberdeen, United Kingdom
1160.53.44005 Boehringer Ingelheim Investigational Site
Headington, Oxford, United Kingdom
1160.53.44004 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.53.44009 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.53.44011 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.53.44006 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1160.53.44012 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00291330     History of Changes
Other Study ID Numbers: 1160.53
2005-001999-12 ( EudraCT Number: EudraCT )
First Posted: February 14, 2006    Key Record Dates
Results First Posted: February 11, 2011
Last Update Posted: June 6, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action