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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00680186
First received: May 16, 2008
Last updated: May 8, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Thromboembolism
Drug: Warfarin
Drug: Dabigatran etexilate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    VTE or any death which occured from randomisation to end of ptp. 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.

  • 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. ] [ Designated as safety issue: No ]
    Symptomatic DVT which occured from randomisation to end of ptp. 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.

  • 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. ] [ Designated as safety issue: No ]
    Symptomatic non-fatal PE which occured from randomisation to end of ptp. 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.

  • Number of Participants Who Died Due to VTE [ Time Frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) ] [ Designated as safety issue: No ]
    VTE - related deaths which occured from randomisation to end of ptp. 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. Hazard ratios and 95% CI were not calculated because of insufficient number of events.

  • 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. ] [ Designated as safety issue: No ]
    Any deaths which occured from randomisation to end of ptp. 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.

  • Number of Participants With Recurrent Symptomatic Fatal and 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. ] [ Designated as safety issue: No ]
    Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. 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.

  • Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout ] [ Designated as safety issue: Yes ]

    Major bleeding events (MBE) are 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) are defined as

    • spontaneous skin hematoma >=25 cm²
    • wound hematoma >=100 cm²
    • spontaneous nose bleed >5 min
    • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
    • spontaneous rectal bleeding
    • 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.


  • Number of Participants With Acute Coronary Syndrome (ACS) [ Time Frame: From first intake of study drug to last contact date ] [ Designated as safety issue: No ]
    Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.

  • Laboratory Analyses [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout ] [ Designated as safety issue: No ]
    Frequency of patients with possible clinically significant abnormalities.


Enrollment: 2589
Study Start Date: April 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Drug: Dabigatran etexilate
150mg bid
Active Comparator: Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Drug: Warfarin
PRN (to maintain a target INR of 2.0-3.0)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • Patients considered unsuitable for inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680186

  Hide Study Locations
Locations
United States, Arkansas
1160.46.01073 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
United States, Florida
1160.46.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
United States, Illinois
1160.46.01068 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Louisiana
1160.46.01071 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, New York
1160.46.01060 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
United States, Ohio
1160.46.01061 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
United States, Oregon
1160.46.01059 Boehringer Ingelheim Investigational Site
Bend, Oregon, United States
1160.46.01063 Boehringer Ingelheim Investigational Site
Corvallis, Oregon, United States
United States, South Carolina
1160.46.01055 Boehringer Ingelheim Investigational Site
Summerville, South Carolina, United States
United States, Washington
1160.46.01062 Boehringer Ingelheim Investigational Site
Bellevue, Washington, United States
Australia, New South Wales
1160.46.61007 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
Australia, Victoria
1160.46.61003 Boehringer Ingelheim Investigational Site
Box Hill, Victoria, Australia
1160.46.61001 Boehringer Ingelheim Investigational Site
Clayton, Victoria, Australia
1160.46.61006 Boehringer Ingelheim Investigational Site
Windsor, Victoria, Australia
Australia, Western Australia
1160.46.61005 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
Brazil
1160.46.55010 Boehringer Ingelheim Investigational Site
Brasília, Brazil
1160.46.55007 Boehringer Ingelheim Investigational Site
Campinas, Brazil
1160.46.55017 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1160.46.55014 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1160.46.55019 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1160.46.55021 Boehringer Ingelheim Investigational Site
Recife, Brazil
1160.46.55016 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ, Brazil
1160.46.55018 Boehringer Ingelheim Investigational Site
São Bernardo do Campo, Brazil
1160.46.55020 Boehringer Ingelheim Investigational Site
São Paulo, Brazil
Bulgaria
1160.46.35901 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1160.46.35903 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1160.46.35906 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1160.46.35905 Boehringer Ingelheim Investigational Site
Varna, Bulgaria
Canada, Alberta
1160.46.02006 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1160.46.02013 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1160.46.02021 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, New Brunswick
1160.46.02004 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Canada, Nova Scotia
1160.46.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1160.46.02002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02015 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1160.46.02019 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1160.46.02008 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02009 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02017 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Canada
1160.46.02020 Boehringer Ingelheim Investigational Site
Quebec, Canada
China
1160.46.86002 Boehringer Ingelheim Investigational Site
Beijing, China
1160.46.86019 Boehringer Ingelheim Investigational Site
Beijing, China
1160.46.86001 Boehringer Ingelheim Investigational Site
Beijing, China
1160.46.86014 Boehringer Ingelheim Investigational Site
Guangzhou, China
1160.46.86015 Boehringer Ingelheim Investigational Site
Guangzhou, China
1160.46.86016 Boehringer Ingelheim Investigational Site
Hangzhou, China
1160.46.86011 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.46.86003 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.46.86004 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.46.86005 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.46.86007 Boehringer Ingelheim Investigational Site
Shenyang, China
1160.46.86017 Boehringer Ingelheim Investigational Site
Shijiazhuang, China
1160.46.86018 Boehringer Ingelheim Investigational Site
Shijiazhuang, China
1160.46.86021 Boehringer Ingelheim Investigational Site
Taiyuan, China
1160.46.86006 Boehringer Ingelheim Investigational Site
Tianjin, China
1160.46.86020 Boehringer Ingelheim Investigational Site
Yinchuan, China
Czech Republic
1160.46.42001 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1160.46.42002 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czech Republic
1160.46.42012 Boehringer Ingelheim Investigational Site
Liberec, Czech Republic
1160.46.42018 Boehringer Ingelheim Investigational Site
Litomerice, Czech Republic
1160.46.42015 Boehringer Ingelheim Investigational Site
Novy Jicin, Czech Republic
1160.46.42005 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice, Czech Republic
1160.46.42017 Boehringer Ingelheim Investigational Site
Prague 4, Czech Republic
1160.46.42014 Boehringer Ingelheim Investigational Site
Tabor, Czech Republic
1160.46.42016 Boehringer Ingelheim Investigational Site
Teplice, Czech Republic
1160.46.42010 Boehringer Ingelheim Investigational Site
Usti nad Labem, Czech Republic
1160.46.42007 Boehringer Ingelheim Investigational Site
Zlin, Czech Republic
Denmark
1160.46.45001 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
1160.46.45008 Boehringer Ingelheim Investigational Site
Esbjerg, Denmark
1160.46.45009 Boehringer Ingelheim Investigational Site
Holbæk, Denmark
1160.46.45004 Boehringer Ingelheim Investigational Site
København NV, Denmark
France
1160.46.3301A Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.46.3301B Boehringer Ingelheim Investigational Site
Brest Cedex, France
1160.46.3315A Boehringer Ingelheim Investigational Site
La Roche-Sur-Yon cedex 09, France
1160.46.3315B Boehringer Ingelheim Investigational Site
La Roche-Sur-Yon cedex 09, France
1160.46.3313A Boehringer Ingelheim Investigational Site
Nantes, France
1160.46.3316A Boehringer Ingelheim Investigational Site
Pessac, France
1160.46.3316B Boehringer Ingelheim Investigational Site
Pessac, France
1160.46.3303G Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303D Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303E Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303F Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303H Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303C Boehringer Ingelheim Investigational Site
St Etienne Cedex 2, France
1160.46.3303A Boehringer Ingelheim Investigational Site
St Priest En Jarez Cedex, France
1160.46.3303B Boehringer Ingelheim Investigational Site
St Priest En Jarez Cedex, France
Hungary
1160.46.36002 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1160.46.36010 Boehringer Ingelheim Investigational Site
Szekesfehervar, Hungary
1160.46.36011 Boehringer Ingelheim Investigational Site
Szombathely, Hungary
India
1160.46.91010 Boehringer Ingelheim Investigational Site
Bangalore, India
1160.46.91006 Boehringer Ingelheim Investigational Site
Bangalore, India
1160.46.91007 Boehringer Ingelheim Investigational Site
Chennai, India
1160.46.91002 Boehringer Ingelheim Investigational Site
Chennai, India
1160.46.91012 Boehringer Ingelheim Investigational Site
Kolkata, India
1160.46.91009 Boehringer Ingelheim Investigational Site
Ludhiana, India
1160.46.91008 Boehringer Ingelheim Investigational Site
Nagpur, India
1160.46.91014 Boehringer Ingelheim Investigational Site
New Delhi, India
1160.46.91005 Boehringer Ingelheim Investigational Site
New Delhi, India
1160.46.91001 Boehringer Ingelheim Investigational Site
Pune, India
1160.46.91004 Boehringer Ingelheim Investigational Site
Pune, India
1160.46.91011 Boehringer Ingelheim Investigational Site
Tamil Nadu, India
1160.46.91013 Boehringer Ingelheim Investigational Site
Vadodara, India
1160.46.91003 Boehringer Ingelheim Investigational Site
Vadodra, India
Israel
1160.46.97202 Boehringer Ingelheim Investigational Site
Afula, Israel
1160.46.97207 Boehringer Ingelheim Investigational Site
Ashkelon, Israel
1160.46.97212 Boehringer Ingelheim Investigational Site
DN Lower Galillee, Israel
1160.46.97211 Boehringer Ingelheim Investigational Site
Haifa, Israel
1160.46.97203 Boehringer Ingelheim Investigational Site
Holon, Israel
1160.46.97205 Boehringer Ingelheim Investigational Site
KfarSaba, Israel
1160.46.97209 Boehringer Ingelheim Investigational Site
Nazareth, Israel
1160.46.97206 Boehringer Ingelheim Investigational Site
Petah Tiqwa, Israel
1160.46.97210 Boehringer Ingelheim Investigational Site
Tel Aviv, Israel
1160.46.97204 Boehringer Ingelheim Investigational Site
Tel Hashomer, Ramat Gan, Israel
1160.46.97201 Boehringer Ingelheim Investigational Site
Zerifin, Israel
Italy
1160.46.39011 Boehringer Ingelheim Investigational Site
Catania, Italy
1160.46.39015 Boehringer Ingelheim Investigational Site
Firenze, Italy
1160.46.39012 Boehringer Ingelheim Investigational Site
Palermo, Italy
1160.46.39007 Boehringer Ingelheim Investigational Site
Reggio Emilia, Italy
1160.46.39013 Boehringer Ingelheim Investigational Site
Verona, Italy
1160.46.39005 Boehringer Ingelheim Investigational Site
Vittorio Veneto (TV), Italy
Korea, Republic of
1160.46.82007 Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
1160.46.82003 Boehringer Ingelheim Investigational Site
Goyang-si, Korea, Republic of
1160.46.82008 Boehringer Ingelheim Investigational Site
Gyeonggi-do, Korea, Republic of
1160.46.82010 Boehringer Ingelheim Investigational Site
Gyeonggi-do, Korea, Republic of
1160.46.82002 Boehringer Ingelheim Investigational Site
Kyunggi-do, Korea, Republic of
1160.46.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1160.46.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1160.46.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1160.46.82009 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Malaysia
1160.46.60001 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru, Malaysia
1160.46.60003 Boehringer Ingelheim Investigational Site
Melaka, Malaysia
1160.46.60004 Boehringer Ingelheim Investigational Site
Pahang, Malaysia
1160.46.60002 Boehringer Ingelheim Investigational Site
Selangor, Malaysia
Netherlands
1160.46.31017 Boehringer Ingelheim Investigational Site
Alkmaar, Netherlands
1160.46.31001 Boehringer Ingelheim Investigational Site
Amersfoort, Netherlands
1160.46.31010 Boehringer Ingelheim Investigational Site
Den Bosch, Netherlands
1160.46.31013 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1160.46.31014 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1160.46.31002 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
1160.46.31004 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
1160.46.31015 Boehringer Ingelheim Investigational Site
Zwolle, Netherlands
New Zealand
1160.46.64004 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
1160.46.64003 Boehringer Ingelheim Investigational Site
Grafton Auckland, New Zealand
1160.46.64002 Boehringer Ingelheim Investigational Site
Otahuhu Auckland, New Zealand
1160.46.64001 Boehringer Ingelheim Investigational Site
Takapuna Auckland, New Zealand
Norway
1160.46.47001 Boehringer Ingelheim Investigational Site
Oslo, Norway
1160.46.47005 Boehringer Ingelheim Investigational Site
Trondheim, Norway
Philippines
1160.46.63001 Boehringer Ingelheim Investigational Site
Manila, Philippines
1160.46.63005 Boehringer Ingelheim Investigational Site
Muntinlupa, Philippines
1160.46.63004 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1160.46.63003 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Poland
1160.46.48004 Boehringer Ingelheim Investigational Site
Kielce, Poland
1160.46.48001 Boehringer Ingelheim Investigational Site
Krakow, Poland
1160.46.48005 Boehringer Ingelheim Investigational Site
Krakow, Poland
1160.46.48003 Boehringer Ingelheim Investigational Site
Poznan, Poland
1160.46.48006 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Russian Federation
1160.46.07021 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1160.46.07007 Boehringer Ingelheim Investigational Site
Ekaterinburg, Russian Federation
1160.46.07016 Boehringer Ingelheim Investigational Site
Krasnodar, Russian Federation
1160.46.07004 Boehringer Ingelheim Investigational Site
Kursk, Russian Federation
1160.46.07009 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.46.07024 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.46.07014 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
1160.46.07005 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
1160.46.07006 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
Singapore
1160.46.65001 Boehringer Ingelheim Investigational Site
Singapore, Singapore
1160.46.65002 Boehringer Ingelheim Investigational Site
Singapore, Singapore
1160.46.65003 Boehringer Ingelheim Investigational Site
Singapore, Singapore
Slovakia
1160.46.42107 Boehringer Ingelheim Investigational Site
Banska Bystrica, Slovakia
1160.46.42106 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
1160.46.42102 Boehringer Ingelheim Investigational Site
Nitra, Slovakia
1160.46.42103 Boehringer Ingelheim Investigational Site
Nove Zamky, Slovakia
South Africa
1160.46.27001 Boehringer Ingelheim Investigational Site
Bryanston, South Africa
1160.46.27013 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1160.46.27007 Boehringer Ingelheim Investigational Site
Centurion, South Africa
1160.46.27014 Boehringer Ingelheim Investigational Site
Kempton Park, South Africa
1160.46.27015 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
1160.46.27002 Boehringer Ingelheim Investigational Site
Morningside, South Africa
1160.46.27012 Boehringer Ingelheim Investigational Site
Plumstead, South Africa
1160.46.27006 Boehringer Ingelheim Investigational Site
Sunninghill, South Africa
Spain
1160.46.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.46.34007 Boehringer Ingelheim Investigational Site
Cartagena. Murcia, Spain
1160.46.34009 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.46.34015 Boehringer Ingelheim Investigational Site
Palma de Mallorca, Spain
1160.46.34014 Boehringer Ingelheim Investigational Site
Sabadell - barcelona, Spain
1160.46.34011 Boehringer Ingelheim Investigational Site
Valencia, Spain
Sweden
1160.46.46002 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1160.46.46010 Boehringer Ingelheim Investigational Site
Kristianstad, Sweden
1160.46.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.46.46008 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.46.46003 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Taiwan
1160.46.88607 Boehringer Ingelheim Investigational Site
ChangHua, Taiwan
1160.46.88604 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1160.46.88606 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1160.46.88608 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1160.46.88609 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Thailand
1160.46.66007 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1160.46.66010 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1160.46.66001 Boehringer Ingelheim Investigational Site
Khon Kaen, Thailand
1160.46.66004 Boehringer Ingelheim Investigational Site
Muang Nakhonratchasima, Thailand
1160.46.66005 Boehringer Ingelheim Investigational Site
Nakhonratchasima, Thailand
1160.46.66006 Boehringer Ingelheim Investigational Site
Nokorn Nayok, Thailand
1160.46.66008 Boehringer Ingelheim Investigational Site
Phayathai, Thailand
Turkey
1160.46.90003 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.46.90004 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.46.90009 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.46.90002 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.46.90007 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.46.90008 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.46.90010 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.46.90001 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
Ukraine
1160.46.38005 Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
United Kingdom
1160.46.44005 Boehringer Ingelheim Investigational Site
Headington, Oxford, United Kingdom
1160.46.44011 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.46.44006 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1160.46.44013 Boehringer Ingelheim Investigational Site
Plymouth, United Kingdom
1160.46.44012 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00680186     History of Changes
Other Study ID Numbers: 1160.46, 2007-002631-86
Study First Received: May 16, 2008
Results First Received: May 4, 2012
Last Updated: May 8, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: Danish Medicines Agency
France: AFSSAPS
Great Britain: MHRA
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drugs Controller General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Korea, Republic of: Korea Drug and Food Administration
Malaysia: National Pharmaceutical Control Bureau
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Multicentre Ethics Committee/Medsafe
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Singapore: Health Sciences Authority,Ministry of Health
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: MCC (Medicines Control Council)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: Ministry of Public Health
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014