Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04631107
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2020-11-06
Brief Title:
AD109 Dose Finding in Mild to Moderate OSA
Sponsor:
Apnimed
Organization:
Apnimed
Study Overview
Official Title:
Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2022-11
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 3-period placebo-controlled crossover phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea
Detailed Description:
Participants underwent initial pre-screening to determine potential study eligibility Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk eg as assessed by STOP-Bang Questionnaire score Only participants who met all non polysomnography PSG enrollment criteria at Visit 1 were eligible for a screening PSG
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