Trials / Completed
CompletedNCT05811247
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 660 (actual)
- Sponsor
- Apnimed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AD109 | Oral administration at bedtime. |
| DRUG | Placebo | Oral administration at bedtime. |
Timeline
- Start date
- 2023-08-28
- Primary completion
- 2025-05-07
- Completion
- 2025-05-07
- First posted
- 2023-04-13
- Last updated
- 2025-11-21
Locations
64 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05811247. Inclusion in this directory is not an endorsement.