At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 646 enrolled
Drug / intervention
AD109 +1 moredrug
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.
Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)
In Brief
A Phase 3 clinical trial evaluating AD109 and Placebo for OSA. Completed, enrolled 646 participants across 73 sites in 2 countries.
Detailed Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOSA
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedApr 2023
Enrollment StartSep 2023
Primary CompletionMar 2025
Study CompletionMar 2025
TodayJul 2026
First PostedApr 14, 2023
Enrollment StartSep 16, 2023
Primary CompletionMar 10, 2025
Study CompletionMar 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.2 years ago
Interventions
AD109drug
Oral administration at bedtime
Placebodrug
Oral administration at bedtime