Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05063994
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2021-05-28
Brief Title:
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Sponsor:
Diurnal Limited
Organization:
Diurnal Limited
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONnECT
Brief 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
Detailed Description:
The study will compare the efficacy safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy IRHC Cortef over a randomized treatment period of up to 28 weeks in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia CAH due to 21 hydroxylase deficiency The primary efficacy assessment of biochemical responder rate and the key secondary assessment of dose responder rate will be assessed after 28 weeks of randomized treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None