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NCT04631107 · ClinicalTrials.gov registry record · Phase 2
AD109 Dose Finding in Mild to Moderate OSA
A Phase 2 study, sponsored by Apnimed.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT04631107: Completed Phase 2 study, sponsored by Apnimed.
NCT04631107 is a Phase 2 study that has completed, run by Apnimed. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631107, a Phase 2 study, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study 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.
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%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.
Interventions
- DRUG AD109 dose1- A
- DRUG AD109 dose2- B
- DRUG Placebo- C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 2 |
What the finished NCT04631107 record still lists
NCT04631107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which AD109 dose1- A is the first listed.
NCT04631107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04631107 about?
NCT04631107 is a clinical study titled "AD109 Dose Finding in Mild to Moderate OSA". 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.
What is the current status of trial NCT04631107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2020-12-22. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT04631107?
The interventions under investigation include: AD109 dose1- A (DRUG), AD109 dose2- B (DRUG), Placebo- C (DRUG).
Who is sponsoring clinical trial NCT04631107?
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 NCT04631107's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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