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

NCT05299554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

DRUG

Chronocort

Hydrocortisone modified-release capsule 5 mg and 10 mg

Sponsors & Collaborators

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • D Merke · National Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-01-15
Completion
2026-01-15
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299554 on ClinicalTrials.gov