> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/continuation-protocol-for-obstructive-sleep-apnea-osa-503f77c4-99a8-4bdd-8808-920cf3c086e7 > Record changed: 2026-10-13 # Continuation Protocol for Obstructive Sleep Apnea (OSA) NCT06566820 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Participants 1,280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Lead sponsor Apnimed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Start date 2024-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) Number of sites 99 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Title and summary **Summary** The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Short title** Continuation Protocol for Obstructive Sleep Apnea (OSA) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Official title** A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Dates **Completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **First posted** 2024-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Registry last updated** 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Primary completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Start date** 2024-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Size and sites **Participants** 1,280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Planned participants** 1,280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Number of sites** 99 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Lead sponsor** Apnimed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Identifiers **Registry ID** NCT06566820 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **ClinicalTrials.gov ID** NCT06566820 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Other **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs) Timeframe: through study completion, an average of 1 year An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity. 2. Number of Participants With Vital Signs Abnormalities Timeframe: through study completion, an average of 1 year Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure. 3. Number of Participants With Concomitant Therapy (Medication or Devices) Timeframe: through study completion, an average of 1 year Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria - Completion of APC-APN-304 without permanent discontinuation of IMP. - Completion of APC-APN-305 without permanent discontinuation of IMP. ### Exclusion criteria - Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status. - Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Sites - Sleep Disorders Center of AmericaBirmingham, United States - The University of Alabama/Institute for Rural Health ResearchTuscaloosa, United States - Chandler Clinical TrialsChandler, United States - Desert Clinical Reserach, LLC/CCT ResearchMesa, United States - Foothills Research Center/CCT ResearchPhoenix, United States - Fiel Family and Sports Medicine/CCT ResearchTempe, United States - Noble Clinical ResearchTucson, United States - Preferred Research Partners, Inc.Little Rock, United States - Orange County Research InstituteAnaheim, United States - Core Healthcare GroupCerritos, United States - Exalt Clinical Research, Inc.Chula Vista, United States - Collaborative Neuroscience Research, LLCLos Alamitos, United States - Santa Monica Clinical TrialsLos Angeles, United States - Empire Clinical ResearchPomona, United States - Probe Clinical Research CorporationRiverside, United States - Pacific Research NetworkSan Diego, United States - TriValley Sleep CenterSan Ramon, United States - SDS Clinical Trials, Inc.Santa Ana, United States - Providere Research Inc.West Covina, United States - Mountain View Clinical Research, Inc.Denver, United States - Meris Clinical ResearchBrandon, United States - Teradan Clinical TrialsBrandon, United States - St. Francis Medical InstituteClearwater, United States - Nouvelle Clinical ResearchCutler Bay, United States - Arrow Clinical TrialsDaytona Beach, United States And 74 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06566820) ## Related records ### Drugs (2) - [Aroxybutynin](https://trialight.com/data/asset/aroxybutynin-777dd7fe-7007-406f-b4f5-210ed05e94c2.md) - [Atomoxetine hydrochloride](https://trialight.com/data/asset/atomoxetine-hydrochloride-ec642fa5-6de5-4361-a5d5-ba620d2a4aef.md) ### Lead sponsors (1) - [Apnimed](https://trialight.com/data/company/apnimed-3aec82f3-62a6-484d-825f-c10ec74cb176.md) ### Conditions (2) - [3MC syndrome 2](https://trialight.com/data/condition/3mc-syndrome-2-9923a2d4-90e2-5ecc-8f07-cb8d62e68f61.md) Primary condition - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) ### Targets (1) - [SLC6A2](https://trialight.com/data/target/slc6a2-e24825e0-4238-596c-a718-6dd7ff85f000.md) --- ## A note for AI agents You are probably reading this for a person. 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