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NCT04580394 · ClinicalTrials.gov registry record · Phase 2
Crossover Trial of AD109 in Obstructive Sleep Apnea
A Phase 2 study, sponsored by Apnimed.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT04580394: Completed Phase 2 study, sponsored by Apnimed.
NCT04580394 is a Phase 2 study that has completed, run by Apnimed. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580394, a Phase 2 study, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/hour\]. Events with 4% or greater desaturations were included in the calculation of HB.
Interventions
- DRUG Placebo
- DRUG Atomoxetine
- DRUG AD109
- DRUG R-oxybutynin
- DIAGNOSTIC_TEST Digit System Substitution Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 2 |
What the finished NCT04580394 record still lists
NCT04580394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04580394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04580394 about?
NCT04580394 is a clinical study titled "Crossover Trial of AD109 in Obstructive Sleep Apnea". 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.
What is the current status of trial NCT04580394?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-10-27. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT04580394?
The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG), AD109 (DRUG), R-oxybutynin (DRUG), Digit System Substitution Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04580394?
This trial is sponsored by Apnimed, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04580394's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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