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NCT05071612 · ClinicalTrials.gov registry record · Phase 2
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
A Phase 2 study, sponsored by Apnimed.
- Completed
- Registry status
- Phase 2
- Development phase
- 294
- Enrollment target
NCT05071612: Completed Phase 2 study, sponsored by Apnimed.
NCT05071612 is a Phase 2 study that has completed, run by Apnimed. The registered enrollment target is 294 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (121% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05071612, a Phase 2 study, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 294 participants
- Enrollment target
Study Summary
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
Primary Outcome
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.
Interventions
- DRUG Placebo
- DRUG AD109
- DRUG Atomoxetine Hydrochloride
- DRUG AD504
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2022-08-03 |
| Phase | Phase 2 |
What the finished NCT05071612 record still lists
NCT05071612 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (121% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05071612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05071612 about?
NCT05071612 is a clinical study titled "Parallel Arm Trial of AD109 and AD504 In Patients With OSA". This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
What is the current status of trial NCT05071612?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 294 participants. The study started on 2021-11-29. Estimated completion is 2022-08-03.
What interventions are being tested in trial NCT05071612?
The interventions under investigation include: Placebo (DRUG), AD109 (DRUG), Atomoxetine Hydrochloride (DRUG), AD504 (DRUG).
Who is sponsoring clinical trial NCT05071612?
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 NCT05071612's enrollment target sits among peer trials
294 190th of 2000 higher than 1,810 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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