An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Phase of Trial: Phase III
Latest Information Update: 01 Nov 2018
At a glance
- Drugs Hydrocortisone (Primary) ; Dexamethasone; Hydrocortisone; Prednisolone; Prednisone
- Indications Congenital adrenal hyperplasia
- Focus Registrational; Therapeutic Use
- Acronyms RESTORE
- Sponsors Diurnal
- 23 Oct 2018 Planned End Date changed from 1 Oct 2020 to 1 Oct 2021.
- 23 Oct 2018 Planned primary completion date changed from 1 Oct 2019 to 1 Oct 2021.
- 23 Oct 2018 Status changed from recruiting to suspended as Protocol re-design required following inconclusive EU Phase III results.