NCT06566820Phase 3Enrolling by invitation

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Study sponsor: Apnimed

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-06-30Estimated

Enrollment · participants1280Estimated

Source updated2025-05-13Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

OSA

Treatments or interventions studied

Aroxybutynin and AtomoxetineDrugAlso known as AD109

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs); description: 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.; timeFrame: through study completion, an average of 1 year; measure: Number of Participants With Vital Signs Abnormalities; description: Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.; timeFrame: through study completion, an average of 1 year; measure: Number of Participants With Concomitant Therapy (Medication or Devices); description: 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.; timeFrame: through study completion, an average of 1 year

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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