Phase 2
Completed N=60
Crossover Trial of AD109 in Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT04580394 ↗Enrolled (actual)
60
Serious AEs
0.4%
Results posted
Jan 2023
Primary outcomePrimary: Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour] — -0.41; -0.36; -0.04; -0.06 Log10HB4%[%min/hour]
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour] |
-0.41; -0.36; -0.04; -0.06 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
- AHI 10 to <20, or AHI ≥20 if meets other PSG criteria
Exclusion Criteria
- History of narcolepsy.
- Clinically significant craniofacial malformation.
- Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
- CPAP should not be used for at least 2 weeks prior to first study PSG
- History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Data sourced from ClinicalTrials.gov (NCT04580394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.