Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia (CONnECT)

    Not Recruiting
  • End date
    Dec 27, 2023
  • participants needed
  • sponsor
    Diurnal Limited
Updated on 29 July 2023
replacement therapy
glucocorticoid therapy


This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.


The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) over a randomized treatment period of up to 52 weeks in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency. The primary efficacy assessment of biochemical responder rate and the key secondary assessment of dose responder rate will be assessed after 52 weeks of randomized treatment.

Condition Congenital Adrenal Hyperplasia
Treatment Cortef, Chronocort
Clinical Study IdentifierNCT05063994
SponsorDiurnal Limited
Last Modified on29 July 2023

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