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DU176b-C-U313_Edoxaban Tosylate in Paediatric Cardiac Diseases

  • Research type

    Research Study

  • 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 age with cardiac diseases at risk of thromboembolic events.

  • IRAS ID

    238090

  • Contact name

    Piers Daubeney

  • Contact email

    p.daubeney@rbht.nhs.uk

  • Sponsor organisation

    Daiichi Sankyo Inc

  • Eudract number

    2017-000475-90

  • Duration of Study in the UK

    2 years, 9 months, 28 days

  • Research summary

    This is a Phase 3 open-label, randomised, parallel-group, multicentre, observational trial to learn if and how edoxaban is better than the current available drugs in children with cardiac diseases at risk of thromboembolic complications, how blood tests may change after taking edoxaban and how safe it is to take this drug.

    About 150 participants will be recruited globally and randomised in a 2:1 ratio into one of two treatment arms.
    1) Edoxaban treatment arm
    2) Standard of Care treatment arm (SOC)

    Of the planned 150 participants, 100 participants will be treated with edoxaban and 50 participants will be given SOC.
    The total duration of the study will be approximately 3 years. The minimum duration for each participant will be 4 months (3 months of main treatment period and 30 days follow up period) and the maximum participation will be 13 months (3 months main treatment period, 9 months extension period and 30 days follow-up).

    USA and the European Union will participate in this study with additional regions included if required.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    18/LO/0034

  • Date of REC Opinion

    27 Mar 2018

  • REC opinion

    Further Information Favourable Opinion