At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
Chronocort +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Chronocort, Cortef, and 1 other intervention for Congenital Adrenal Hyperplasia. Completed, enrolled 55 participants across 21 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Adrenal Hyperplasia
CountriesFrance, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartMay 2022
Primary CompletionFeb 2024
TodayJul 2026
First PostedOct 1, 2021
Enrollment StartMay 24, 2022
Primary CompletionFeb 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.8 years ago
Interventions
Chronocortdrug
Over-encapsulated hydrocortisone modified-release capsule for oral administration.
Cortefdrug
Over-encapsulated hydrocortisone immediate-release tablet for oral administration.
Placeboother
Matching placebo