Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Continuation Protocol for Obstructive Sleep Apnea OSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine AD109 in Obstructive Sleep Apnea
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination drug composed of aroxybutynin and atomoxetine designated AD109 is being developed by Apnimed for the treatment of obstructive sleep apnea OSA The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies APC-APN-304 or APC-APN-305
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None