← Back to Search

Combination Drug

AD109 for Obstructive Sleep Apnea

Phase 3
Recruiting
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is testing a new drug called AD109, which is a combination of aroxybutynin and atomoxetine, for treating obstructive sleep apnea (OSA). It is for

Who is the study for?
This trial is for individuals who have completed one of the parent Phase 3 studies, APC-APN-304 or APC-APN-305, and are diagnosed with obstructive sleep apnea (OSA). Specific eligibility details are not provided but typically include meeting certain health standards.
What is being tested?
The study tests a combination drug called AD109, made up of aroxybutynin and atomoxetine. It's an open label continuation from previous double-blind studies aimed at treating OSA in those who've already participated.
What are the potential side effects?
Potential side effects for aroxybutynin may include dry mouth, constipation, and blurred vision. Atomoxetine can cause stomach upset, decreased appetite, dizziness, or mood swings. Side effects vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
Number of Participants With Concomitant Therapy (Medication or Devices)
Number of Participants With Vital Signs Abnormalities

Side effects data

From 2008 Phase 4 trial • 45 Patients • NCT00181766
58%
Dry Mouth
49%
Gastrointestinal
49%
Insomnia
49%
Tired/fatigued
38%
Headache
33%
Decreased appetite
29%
Warmth/flushing/sweating
24%
Colds/allergies/infections
22%
Lightheaded/dizzy
20%
Musculoskeletal discomfort
20%
Tension/jitteriness
16%
Mood change
16%
Sexual function
13%
Urinary hesitancy
11%
Vision/ocular
11%
Neurologic
9%
Injury
9%
Muscle twitch/tremor
9%
Feeling cold
7%
Impaired concentration
7%
Palpitations
7%
Tingling sensation
7%
Vivid dreams
4%
Anxiety
4%
Bad taste
4%
Chest discomfort
4%
Skin changes
2%
Shortness of breath
2%
Increased appetite
2%
Paresthesia
2%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Strattera (Atomoxetine)

Trial Design

1Treatment groups
Experimental Treatment
Group I: AD109Experimental Treatment1 Intervention
Open Label AD109

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
16 Previous Clinical Trials
2,375 Total Patients Enrolled
Ron Farkas, MDStudy DirectorApnimed
2 Previous Clinical Trials
172 Total Patients Enrolled
~853 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top