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A Phase III study of efficacy, safety and tolerability of Chronocort compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia

Trial Profile

A Phase III study of efficacy, safety and tolerability of Chronocort compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2019

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At a glance

  • Drugs Hydrocortisone (Primary) ; Dexamethasone; Prednisolone
  • Indications Congenital adrenal hyperplasia
  • Focus Registrational; Therapeutic Use
  • Sponsors Diurnal
  • Most Recent Events

    • 09 May 2019 According to a Diurnal media release, an Intent to Submit letter to the European Medicines Agency (EMA) for a Market Authorisation Application (MAA) for Chronocort has been tendered. This follows a positive meeting with the EMA in March 2019 and written formal Scientific Advice from the EMA in April 2019 confirming the current clinical and regulatory path for Chronocort. This scientific advice was based on this study and the open-label safety extension study.
    • 11 Dec 2018 Results of a post-hoc analysis published in the Diurnal Media Release
    • 08 Oct 2018 According to a Diurnal media release, primary endpoint ( (Change from baseline in 17-OHP) has not been met.
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