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

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

Clinical Trial Summary

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.

Clinical Trial Description

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 28 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 28 weeks of randomized treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05063994
Study type Interventional
Source Diurnal Limited
Contact
Status Completed
Phase Phase 3
Start date December 13, 2021
Completion date February 2, 2024
View Details
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