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Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy — RESTORE  

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
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

Clinical Trial Summary

This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA.

Clinical Trial Description

It will compare the efficacy, safety and tolerability of twice daily Chronocort® with standard care (using the participant's usual individualized standard glucocorticoid regimen) over a treatment period of 52 weeks in participants aged 16 years and over with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03532022
Study type Interventional
Source Diurnal Limited
Contact
Status Withdrawn
Phase Phase 3
Start date October 4, 2018
Completion date July 9, 2021
View Details
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