Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580394
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-10-02
Brief Title:
Crossover Trial of AD109 in Obstructive Sleep Apnea
Sponsor:
Apnimed
Organization:
Apnimed
Study Overview
Official Title:
Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
This is a randomized 4-period placebo-controlled crossover phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea
Detailed Description:
The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic PSG testing with dosing of one of the following 4 treatments AD109 atomoxetine R-oxybutynin or placebo Participants will return 2 weeks after their final crossover PSG for an end of study EOS visit
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