Menu
Enrolling by invitation NCT06566820

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Phase III Interventional OSA

For patients and families

In plain language

Fill the application

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aroxybutynin and Atomoxetine.
Who it may be relevant to
Registry conditions: OSA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea

Overview

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

  • Drug Aroxybutynin and Atomoxetine
    Fixed Dose Combination

Primary outcome measures

  • Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs) [Time frame: through study completion, an average of 1 year]
  • Number of Participants With Vital Signs Abnormalities [Time frame: through study completion, an average of 1 year]
  • Number of Participants With Concomitant Therapy (Medication or Devices) [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 93 centers
  • Sleep Disorders Center of America — Birmingham
  • The University of Alabama/Institute for Rural Health Research — Tuscaloosa
  • Chandler Clinical Trials — Chandler
  • Desert Clinical Reserach, LLC/CCT Research — Mesa
  • Foothills Research Center/CCT Research — Phoenix
  • Fiel Family and Sports Medicine/CCT Research — Tempe
  • Noble Clinical Research — Tucson
  • Preferred Research Partners, Inc. — Little Rock
  • … and 85 more centers
Canada · 6 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06566820 · APC-APN-306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗