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Combination Drug
AD109 for Obstructive Sleep Apnea
Phase 3
Waitlist Available
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
Pivotal Trial
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 • NCT0018176658%
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)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,395 Total Patients Enrolled
Ron Farkas, MDStudy DirectorApnimed
2 Previous Clinical Trials
172 Total Patients Enrolled