Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00329238
First received: May 23, 2006
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 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.


Condition Intervention Phase
Thromboembolism
Drug: Dabigatran
Drug: Warfarin
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, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Composite of Recurrent VTE or VTE Death at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

  • Composite of Recurrent VTE or VTE Death at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.


Secondary Outcome Measures:
  • Composite of Recurrent VTE or All Cause Death at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  • Composite of Recurrent VTE or All Cause Death at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  • Deep Vein Thrombosis (DVT) at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  • DVT at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  • Symptomatic Pulmonary Embolism (PE) at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  • Symptomatic Pulmonary Embolism (PE) at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  • Deaths Related to VTE at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  • Deaths Related to VTE at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  • Deaths of All Causes at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  • Deaths of All Causes at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  • Number of Participants With Bleeding Events [ Time Frame: first intake of study drug until 6 days following last intake of study drug ] [ Designated as safety issue: Yes ]

    MBE (major bleeding event) if it fulfilled at least one of the following criteria

    • 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.

    Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

    CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

    • Spontaneous skin haematoma ≥25 cm2
    • Spontaneous nose bleed >5 min duration
    • Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
    • Spontaneous rectal bleeding
    • Gingival bleeding >5 min
    • Bleeding leading to hospitalisation or requiring surgical treatment
    • Bleeding leading to a transfusion of <2 units of whole blood or red cells
    • Any other bleeding event considered clinically relevant by the investigator

  • Laboratory Analysis [ Time Frame: 18 months + 30 days follow up ] [ Designated as safety issue: No ]
    Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

  • Number of Participants With Definite Acute Coronary Syndrome (ACS) [ Time Frame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination ] [ Designated as safety issue: No ]
    All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.


Enrollment: 2867
Study Start Date: May 2006
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
Active Comparator: 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
Drug: Warfarin
Warfarin dosed individually to maintain INR 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:

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)
  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: NCT00329238

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United States, Alabama
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United States, Connecticut
1160.47.01056 Boehringer Ingelheim Investigational Site
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1160.47.01044 Boehringer Ingelheim Investigational Site
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Usti nad Labem, Czech Republic
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1160.47.45002 Boehringer Ingelheim Investigational Site
Kolding, Denmark
1160.47.45004 Boehringer Ingelheim Investigational Site
København NV, Denmark
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1160.47.35801 Boehringer Ingelheim Investigational Site
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1160.47.35802 Boehringer Ingelheim Investigational Site
Jyväskylä, Finland
1160.47.35805 Boehringer Ingelheim Investigational Site
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1160.47.35803 Boehringer Ingelheim Investigational Site
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France
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Brest Cedex, France
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Brest Cedex, France
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Brest Cedex, France
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Brest Cedex, France
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Brest Cedex, France
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Brest Cedex, France
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Lorient, France
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St Etienne Cedex 2, France
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St Etienne Cedex 2, France
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Vandoeuvre les Nancy, France
Germany
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Dresden, Germany
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Köln, Germany
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Mannheim, Germany
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Mannheim, Germany
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München, Germany
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München, Germany
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Püttlingen, Germany
Greece
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Athens, Greece
Hungary
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1160.47.36003 Boehringer Ingelheim Investigational Site
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1160.47.36011 Boehringer Ingelheim Investigational Site
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1160.47.36010 Boehringer Ingelheim Investigational Site
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1160.47.91011 Boehringer Ingelheim Investigational Site
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1160.47.91007 Boehringer Ingelheim Investigational Site
Mysore, India
1160.47.91010 Boehringer Ingelheim Investigational Site
New Delhi, India
1160.47.91003 Boehringer Ingelheim Investigational Site
New Delhi, India
1160.47.91006 Boehringer Ingelheim Investigational Site
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1160.47.91005 Boehringer Ingelheim Investigational Site
Pune, India
1160.47.91001 Boehringer Ingelheim Investigational Site
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1160.47.91014 Boehringer Ingelheim Investigational Site
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Vadodara, India
Israel
1160.47.97202 Boehringer Ingelheim Investigational Site
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1160.47.97207 Boehringer Ingelheim Investigational Site
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1160.47.97211 Boehringer Ingelheim Investigational Site
Haifa, Israel
1160.47.97203 Boehringer Ingelheim Investigational Site
Holon, Israel
1160.47.97205 Boehringer Ingelheim Investigational Site
Kfar Saba, Israel
1160.47.97206 Boehringer Ingelheim Investigational Site
Petach Tikva, Israel
1160.47.97208 Boehringer Ingelheim Investigational Site
Rehovot, Israel
1160.47.97210 Boehringer Ingelheim Investigational Site
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1160.47.97204 Boehringer Ingelheim Investigational Site
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Italy
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1160.47.39006 Boehringer Ingelheim Investigational Site
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1160.47.39008 Boehringer Ingelheim Investigational Site
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Vittorio Veneto, Italy
Mexico
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Monterrey, Mexico
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Amersfoort, Netherlands
1160.47.31007 Boehringer Ingelheim Investigational Site
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1160.47.31014 Boehringer Ingelheim Investigational Site
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1160.47.31005 Boehringer Ingelheim Investigational Site
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1160.47.31004 Boehringer Ingelheim Investigational Site
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Rotterdam, Netherlands
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1160.47.64004 Boehringer Ingelheim Investigational Site
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1160.47.64002 Boehringer Ingelheim Investigational Site
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Rud, Norway
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Trondheim, Norway
Poland
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1160.47.48005 Boehringer Ingelheim Investigational Site
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1160.47.35104 Boehringer Ingelheim Investigational Site
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1160.47.35101 Boehringer Ingelheim Investigational Site
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1160.47.35105 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1160.47.35102 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
Russian Federation
1160.47.07022 Boehringer Ingelheim Investigational Site
Belgorod, Russian Federation
1160.47.07021 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1160.47.07011 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1160.47.07007 Boehringer Ingelheim Investigational Site
Ekaterinburg, Russian Federation
1160.47.07016 Boehringer Ingelheim Investigational Site
Krasnodar, Russian Federation
1160.47.07004 Boehringer Ingelheim Investigational Site
Kursk, Russian Federation
1160.47.07010 Boehringer Ingelheim Investigational Site
Novosibirsk, Russian Federation
1160.47.07020 Boehringer Ingelheim Investigational Site
Omsk, Russian Federation
1160.47.07018 Boehringer Ingelheim Investigational Site
Pskov, Russian Federation
1160.47.07023 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.47.07025 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.47.07009 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.47.07024 Boehringer Ingelheim Investigational Site
Rostov-na-Donu, Russian Federation
1160.47.07001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1160.47.07017 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1160.47.07002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1160.47.07019 Boehringer Ingelheim Investigational Site
Tyumen, Russian Federation
1160.47.07014 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
1160.47.07005 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
1160.47.07006 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
Slovakia
1160.47.42107 Boehringer Ingelheim Investigational Site
Banska Bystrica, Slovakia
1160.47.42106 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
1160.47.42102 Boehringer Ingelheim Investigational Site
Nitra, Slovakia
1160.47.42103 Boehringer Ingelheim Investigational Site
Nove Zamky, Slovakia
1160.47.42104 Boehringer Ingelheim Investigational Site
Zilina, Slovakia
South Africa
1160.47.27006 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.47.27002 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.47.27001 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1160.47.27007
Pretoria, South Africa
1160.47.27003 Boehringer Ingelheim Investigational Site
Randburg, South Africa
1160.47.27005 Boehringer Ingelheim Investigational Site
Roodepoort, South Africa
Spain
1160.47.34006 Boehringer Ingelheim Investigational Site
Alicante, Spain
1160.47.34012 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
1160.47.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.47.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.47.34007 Boehringer Ingelheim Investigational Site
Cartagena. Murcia, Spain
1160.47.34003 Boehringer Ingelheim Investigational Site
Cuenca, Spain
1160.47.34009 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.47.34004 Boehringer Ingelheim Investigational Site
Santander, Spain
1160.47.34011 Boehringer Ingelheim Investigational Site
Valencia, Spain
Sweden
1160.47.46002 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
1160.47.46006 Boehringer Ingelheim Investigational Site
Jönköping, Sweden
1160.47.46007 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.47.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.47.46008 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1160.47.46005 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden
1160.47.46003 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Turkey
1160.47.90003 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.47.90005 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.47.90004 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.47.90002 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.47.90001 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.47.90007 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1160.47.90006 Boehringer Ingelheim Investigational Site
Izmir, Turkey
Ukraine
1160.47.38002 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1160.47.38006 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1160.47.38005 Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
1160.47.38003 Boehringer Ingelheim Investigational Site
Zaporozhye, Ukraine
United Kingdom
1160.47.44005 Boehringer Ingelheim Investigational Site
Headington, Oxford, United Kingdom
1160.47.44009 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.47.44011 Boehringer Ingelheim Investigational Site
London, United Kingdom
1160.47.44006 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1160.47.44012 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: NCT00329238     History of Changes
Other Study ID Numbers: 1160.47, 2005-002536-94
Study First Received: May 23, 2006
Results First Received: August 10, 2011
Last Updated: May 8, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
China: Ministry of Health
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Comitato Etico delle Aziende Sanitarie dell'Umbria di Perugia
Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS Federal Commission for Protection against Sanitary Hazards
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines and Health Products
Sweden: Medical Products Agency Regional Ethical Review Board
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
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 October 23, 2014