Continuation Protocol for Obstructive Sleep Apnea (OSA)

Condition(s) studied

Investigational drug(s) / intervention(s)

Aroxybutynin and Atomoxetine: Fixed Dose Combination

Study 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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs) — 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.
• Number of Participants With Vital Signs Abnormalities — 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.
• Number of Participants With Concomitant Therapy (Medication or Devices) — 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.

Trial sites (99)

+ 59 more sites — see the full list on the official registry below.