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NCT06566820

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Enrolling by Invitation
PHASE3Ages 18+Interventional
Apnimed
~1,280 participants
Updated 2025-05-13 on ClinicalTrials.gov
What's tested:Aroxybutynin and Atomoxetine

At a glance

Recruiting sites
0 of 99 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
Measured over through study completion, an average of 1 year
+2 more outcomes measured

Conditions

OSA

Explore related trials

Obstructive Sleep Apnea

Where it's being run

99 sites across 32 states
Florida17
California11
Texas7
North Carolina6
Arizona5
Georgia5
Michigan4
South Carolina4

Study leadership

  • Ron Farkas, MD · STUDY_DIRECTOR · Apnimed

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Completion of APC-APN-304 without permanent discontinuation of IMP.
Completion of APC-APN-305 without permanent discontinuation of IMP.

Exclusion

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.

What this trial measures

  • 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 Abnormalitiesthrough 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.