Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Dabigatran

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    74 result(s) found for: Dabigatran. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2014-000583-18 Sponsor Protocol Number: 1160.108 Start Date*: 2014-07-25
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years
    Medical condition: Secondary prevention of venous thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FI (Completed) AT (Completed) GR (Completed) IT (Completed) LT (Completed) CZ (Completed) BE (Completed) SK (Completed) SE (Temporarily Halted) BG (Completed) FR (Completed) HU (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002114-12 Sponsor Protocol Number: 1160.106 Start Date*: 2013-09-20
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: Open-label, randomized, parallel-group, active-controlled, multi-centre, non-inferiority study of dabigatran etexilate versus standard of care for venous thromboembolism treatment in children from ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10066899 Venous thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Completed) BE (Completed) ES (Completed) SE (Completed) FI (Completed) SK (Completed) GR (Completed) NO (Completed) IT (Completed) AT (Completed) BG (Completed) Outside EU/EEA FR (Completed) HU (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000388-41 Sponsor Protocol Number: OZR-2013-27 Start Date*: 2014-05-05
    Sponsor Name:The Rotterdam Eye Hospital
    Full Title: Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal ...
    Medical condition: Ocular accessibility of dabigatran in patients with retinal detachment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004249-29 Sponsor Protocol Number: DALMATION/7212 Start Date*: 2015-10-30
    Sponsor Name:The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Full Title: An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers
    Medical condition: Future use for VTE prophylaxis.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002177-37 Sponsor Protocol Number: 1321.7 Start Date*: 2016-06-01
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilat...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10066899 Venous thromboembolism LLT
    18.1 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) CZ (Completed) IT (Completed) DE (Completed) Outside EU/EEA GR (Completed) HU (Completed) BE (Completed) ES (Prematurely Ended) BG (Completed) AT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-005248-17 Sponsor Protocol Number: 1160.71 Start Date*: 2008-11-20
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowle...
    Medical condition: This is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) FI (Completed) DE (Completed) DK (Completed) AT (Completed) GB (Completed) SK (Completed) FR (Completed) BE (Completed) HU (Completed) PL (Completed) CZ (Completed) IT (Completed) PT (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004813-41 Sponsor Protocol Number: 1321.3 Start Date*: 2014-05-26
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran ...
    Medical condition: Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10019524 Hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Completed) PT (Completed) SE (Completed) ES (Completed) FI (Completed) EE (Completed) LV (Prematurely Ended) CZ (Completed) IT (Completed) SK (Completed) NL (Completed) BE (Completed) AT (Completed) NO (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004357-13 Sponsor Protocol Number: CTH201401 Start Date*: 2015-03-18
    Sponsor Name:Odense University Hospital
    Full Title: Coagaulation in patients with atrial fibrillation: The effect of dabigatran
    Medical condition: Atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004849 10071667 Persistent atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002204-24 Sponsor Protocol Number: 1160.203 Start Date*: 2014-12-17
    Sponsor Name:University Medical Center Groningen
    Full Title: REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT
    Medical condition: Healthy male volunteers. Study assessing the effect of a single 50IU/Kg dose of Beriplex on the anticoagulant effect of Dabigatran. This is of interest when rapid reversal of its effect is mandate...
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001259-22 Sponsor Protocol Number: 1160.105 Start Date*: 2014-08-05
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: open-label, single dose, tolerability, Pharmacokinetic/Pharmacodynamics and safety study of dabigatran etexilate given at the end of standard anticoagulant therapy in children aged less than 1 yea...
    Medical condition: venous thrombotic event
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004866 10066899 Venous thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) IT (Prematurely Ended) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003444-24 Sponsor Protocol Number: 1160.189 Start Date*: 2014-11-21
    Sponsor Name:Unilfarma - União Internacional de Lab. Farmacêuticos, Lda.
    Full Title: Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acet...
    Medical condition: A study to compare dabigatran etexilate to acetylsalicylic acid in preventing recurrent stroke for patients that already had a stroke caused by an embolus (clot). Despite testing, it is unknown wh...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10067167 Cerebellar embolism PT
    18.1 10029205 - Nervous system disorders 10014498 Embolic stroke PT
    18.1 10029205 - Nervous system disorders 10060839 Embolic cerebral infarction PT
    18.1 10029205 - Nervous system disorders 10074422 Brain stem embolism PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) DE (Completed) BE (Completed) AT (Completed) HU (Completed) IT (Completed) SE (Completed) SI (Completed) ES (Completed) CZ (Completed) SK (Completed) PL (Completed) HR (Completed) GR (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002263-96 Sponsor Protocol Number: 39486 Start Date*: 2012-07-11
    Sponsor Name:MUMC
    Full Title: dabigatran and rivaroxaban: prediction of anticoagulant effect
    Medical condition: non valvular atrial fibrillation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022685-27 Sponsor Protocol Number: 1160.113 Start Date*: 2011-09-02
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: A Randomised, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt
    Medical condition: anticoagulation following mechanical heart valve surgery
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022891 - Investigations 10053349 Pharmacokinetic study LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) NL (Completed) BE (Completed) NO (Completed) DK (Completed) DE (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-001988-21 Sponsor Protocol Number: 1160.48 Start Date*: 2004-11-01
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsu...
    Medical condition: Prevention of venous thromboembolism following primary elective total hip replacement surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) AT (Completed) DE (Completed) HU (Completed) DK (Completed) CZ (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-001317-34 Sponsor Protocol Number: 1160.25 Start Date*: 2004-11-01
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate caps...
    Medical condition: Prevention of venous thromboembolism following primary elective total knee replacement surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) DE (Completed) AT (Completed) HU (Completed) DK (Completed) CZ (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-004301-99 Sponsor Protocol Number: 1160.67 Start Date*: 2008-02-06
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: RandomisEd Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin an...
    Medical condition: Acute coronary syndromes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FI (Completed) DE (Completed) ES (Completed) BE (Completed) GB (Completed) IE (Completed) CZ (Completed) HU (Completed) FR (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003569-91 Sponsor Protocol Number: NL62896 Start Date*: 2017-12-08
    Sponsor Name:Hagaziekenhuis
    Full Title: The effect of body weight on trough concentrations of DOACs in patients.
    Medical condition: No medical condition will be investigated. This study will only investigate the effect of body weight on through concentrations of direct oral anticoagulants (DOACs)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003201-26 Sponsor Protocol Number: 1160.186 Start Date*: 2014-07-21
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. tr...
    Medical condition: Patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    19.0 10042613 - Surgical and medical procedures 10065608 Percutaneous coronary intervention PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) GR (Completed) DE (Completed) PT (Completed) HU (Completed) ES (Completed) FI (Completed) NL (Completed) CZ (Completed) AT (Completed) IT (Completed) BE (Completed) IE (Completed) SK (Completed) SI (Completed) GB (Completed) BG (Completed) HR (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-006866-27 Sponsor Protocol Number: 1160.88 Start Date*: 2012-03-15
    Sponsor Name:Boehringer Ingelheim (Canada) Ltd./Ltée
    Full Title: Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years
    Medical condition: Venous Thrombotic Event
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10066899 Venous thromboembolism LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-013618-29 Sponsor Protocol Number: 1160.89 Start Date*: 2010-08-17
    Sponsor Name:Boehringer Ingelheim France
    Full Title: Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years...
    Medical condition: Venous Thrombotic Event
    Disease: Version SOC Term Classification Code Term Level
    12.0 10066899 Venous thromboembolism LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) AT (Prematurely Ended) NL (Prematurely Ended) ES (Completed) LT (Prematurely Ended) SK (Completed) LV (Prematurely Ended) IT (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Jun 07 02:02:37 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA