drugset / Trial / NCT05299554

Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia

NCT05299554

Phase 3 Completed 76 enrolled Immedica Pharma AB
NaSingle-groupOpen-labelTreatment

Summary

This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).

Timeline

Start
2022-04-01
Primary completion
2026-01-15
Completion
2026-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 5 mg Oral
Subject Hydrocortisone Other / unclassified 10 mg Oral