At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 91 enrolled
Drug / intervention
Hydrocortisonedrug
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 Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Hydrocortisone for Congenital Adrenal Hyperplasia. Completed, enrolled 91 participants across 1 site.
Detailed Summary
Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will be offered the opportunity either to continue Chronocort® therapy or to switch from their current glucocorticoid therapy to Chronocort® in this open-label study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Adrenal Hyperplasia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedFeb 2017
Primary CompletionJul 2022
TodayJul 2026
First PostedFeb 23, 2017
Enrollment StartAug 18, 2016
Primary CompletionJul 13, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.4 years ago
Interventions
Hydrocortisonedrug
Modified release hydrocortisone