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Clinical trials for Edoxaban

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
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    • 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   44346   clinical trials with a EudraCT protocol, of which   7374   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 ).  
     
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    49 result(s) found for: Edoxaban. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2022-004136-26 Sponsor Protocol Number: S67063 Start Date*: 2023-06-28
    Sponsor Name:KU Leuven/UZ Leuven
    Full Title: Pharmacokinetics of edoxaban in geriatric patients with atrial fibrillation
    Medical condition: Stroke prevention in atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10016566 Fibrillation atrial LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001265-17 Sponsor Protocol Number: 3.0 Start Date*: 2018-08-07
    Sponsor Name:Turku University Central Hospital
    Full Title: Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis (EdoRot).
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2016-000991-49 Sponsor Protocol Number: DU176b-D-U312 Start Date*: 2016-11-11
    Sponsor Name:Daiichi Sankyo, Inc.
    Full Title: A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, CONTROLLED TRIAL TO EVALUATE THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EDOXABAN AND TO COMPARE THE EFFICACY AND SAFETY OF EDOXABAN WITH STANDARD O...
    Medical condition: venous thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004866 10066899 Venous thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) PT (Completed) HU (Completed) DE (Completed) ES (Ongoing) SI (Completed) DK (Completed) NL (Completed) HR (Completed) BG (Completed) NO (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004450-24 Sponsor Protocol Number: PHIX-IT Start Date*: 2019-08-01
    Sponsor Name:Tergooi Hospital, dep of internal medicine
    Full Title: A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifen
    Medical condition: If there are increased plasma levels of edoxaban when used concomitantly with the P-glycoproteïne inhibitor tamoxifen for the treatment of venous thromboembolism in patients with breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000475-90 Sponsor Protocol Number: DU176b-C-U313 Start Date*: 2018-03-27
    Sponsor Name:Daiichi Sankyo Inc
    Full Title: AN OPEN-LABEL, RANDOMISED, PARALLEL-GROUP, MULTICENTRE, OBSERVATIONAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF EDOXABAN TOSYLATE IN CHILDREN FROM 38 WEEKS GESTATIONAL AGE TO LESS THAN 18 YEARS OF A...
    Medical condition: thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10043566 Thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed) ES (Completed) AT (Completed) FR (Completed) PL (Completed) HR (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-003833-14 Sponsor Protocol Number: GOIRC-05-2018 Start Date*: 2019-03-21
    Sponsor Name:GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    Full Title: A Phase IV study on impact of Edoxaban treatment in Italian cancer patients with venous thromboembolism (EDOI Cancer Study) during antineoplastic therapy
    Medical condition: Venous thromboembolism event associated with cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004866 10066899 Venous thromboembolism LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028997 Neoplasm malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005732-18 Sponsor Protocol Number: DU176b-A-U157 Start Date*: 2016-06-29
    Sponsor Name:Daiichi Sankyo , Inc.
    Full Title: A Phase 1, Open-Label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
    Medical condition: Edoxaban is being investigated for use in pediatric patients who may require anticoagulation therapy.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10010495 Congenital heart disease NOS LLT
    19.0 100000004851 10057396 Thrombophilia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) FR (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002504-39 Sponsor Protocol Number: HERO-19 Start Date*: 2020-11-10
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Hamburg Edoxaban foR anticoagulation in COvid-19 study
    Medical condition: COVID-19 [Coronavirus disease 2019]
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001795-30 Sponsor Protocol Number: DU176b-C-E314 Start Date*: 2016-11-11
    Sponsor Name:Daiichi Sankyo, Inc.
    Full Title: Evaluation of Edoxaban in Anticoagulant Naïve Patients with Non-Valvular Atrial Fibrillation (NVAF) and high Creatinine Clearance
    Medical condition: Non-Valvular Atrial Fibrillation (NVAF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) CZ (Completed) EE (Completed) LT (Completed) SK (Completed) DK (Completed) HU (Completed) ES (Completed) BE (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003148-21 Sponsor Protocol Number: DU176b-F-E308 Start Date*: 2014-06-17
    Sponsor Name:Daiichi Sankyo Development Ltd
    Full Title: A prospective, randomised, open-label, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU-176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoi...
    Medical condition: Stroke and thromboembolism prevention in patients with non-valvular atrial fibrillation (NVAF) undergoing planned electrical cardioversion.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) DE (Completed) GB (Completed) HU (Completed) IT (Completed) DK (Completed) ES (Completed) AT (Completed) CZ (Completed) NL (Completed) RO (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-001410-20 Sponsor Protocol Number: NL81154.091.22 Start Date*: 2022-09-21
    Sponsor Name:Radboud university medical center
    Full Title: Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer
    Medical condition: Prostate cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002234-32 Sponsor Protocol Number: CONVINCE Start Date*: 2020-11-24
    Sponsor Name:Insel Gruppe AG - Bern University Hospital, Department of Cardiology
    Full Title: Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19)
    Medical condition: Patients ≥ 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) IT (Prematurely Ended)
    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: 2019-002075-33 Sponsor Protocol Number: ENRICH-AF Start Date*: 2020-05-05
    Sponsor Name:Hamilton Health Sciences, through its Population Health Research Institute
    Full Title: Edoxaban for intracranial hemorrhage survivors with atrial fibrillation
    Medical condition: High risk atrial fibrillation patients with previous intracranial hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10018985 Haemorrhage intracranial PT
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NO (Prematurely Ended) DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) BE (Trial now transitioned) CZ (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) SK (Trial now transitioned) DK (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003100-13 Sponsor Protocol Number: KKSH-154 Start Date*: 2020-08-03
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention
    Medical condition: Nonvalvular Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001759-38 Sponsor Protocol Number: K675 Start Date*: 2019-12-04
    Sponsor Name:Ruprecht-Karls University Heidelberg Medical Faculty, University Hospital represented in law by its commercial director
    Full Title: Pharmacokinetics of a microdosed cocktail containing rivaroxaban, apixaban and edoxaban in children with congenital heart defects
    Medical condition: 20 children with non-cyanotic congenital heart defects especially atrial septal defects (ASD) and ventricular septal defects (VSD) in admitted to the paediatric cardiology wards will be included. T...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001425-26 Sponsor Protocol Number: REDOX19032019 Start Date*: 2019-07-04
    Sponsor Name:Thoraxcentrum Erasmus MC
    Full Title: Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation
    Medical condition: aortic stenosis
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003930-26 Sponsor Protocol Number: DU-176B-C-U4001 Start Date*: 2017-05-15
    Sponsor Name:Daiichi Sankyo Inc.
    Full Title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation – In Atrial Fibrillation. ENVISAGE-TAVI AF
    Medical condition: Patients with atrial fibrillation (AF) and indication to chronic oral anticoagulant after transcatheter aortic valve implantation (TAVI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014290-40 Sponsor Protocol Number: DU176b-D-U305 Start Date*: 2010-02-10
    Sponsor Name:Daiichi Sankyo Development Limited
    Full Title: A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfar...
    Medical condition: Reduction of the risk of symptomatic recurrent venous thromboembolic complications in patients with acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037377 Pulmonary embolism PT
    14.1 10047065 - Vascular disorders 10051055 Deep vein thrombosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed) SE (Completed) FR (Completed) EE (Completed) BE (Completed) AT (Completed) ES (Completed) DK (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003009-88 Sponsor Protocol Number: DU176b-E-U210 Start Date*: 2012-12-27
    Sponsor Name:Daiichi Sankyo Development Ltd
    Full Title: A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, MULTI-CENTER STUDY OF ADDING EDOXABAN OR CLOPIDOGREL TO ASPIRIN TO MAINTAIN PATENCY IN SUBJECTS WITH PERIPHERAL ARTERIAL DISEASE FOLLOWING FEMOROPOPLIT...
    Medical condition: Edoxaban is being investigated for use in PAD subjects after femoropopliteal endovascular interventions with/without stent placement for the maintenance of patency and prevention of re-intervention.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004866 10067825 Peripheral arterial disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed) AT (Completed)
    Trial results: View results
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    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.

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