OSA
Conditions
Keywords
Obstructive Sleep Apnea
Brief 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.
Interventions
DRUGAroxybutynin and Atomoxetine
Fixed Dose Combination
Sponsors
Apnimed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Outcome results
None listed