drugset / Trial / NCT05063994

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

NCT05063994

Phase 3 Completed 55 enrolled Neurocrine UK Limited
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-05-24
Primary completion
2024-02-02
Completion
2024-02-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocortisone Other / unclassified 15 mg Oral
Comparator Hydrocortisone Other / unclassified 20 mg Oral
Comparator Hydrocortisone Other / unclassified 25 mg Oral
Comparator Hydrocortisone Other / unclassified 30 mg Oral