Continuation Protocol for Obstructive Sleep Apnea (OSA)

NCT06566820
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Enrolling by invitation
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Participants
1,280
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Lead sponsor
Apnimed
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Start date
2024-07-03
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Number of sites
99
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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.
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Short title
Continuation Protocol for Obstructive Sleep Apnea (OSA)
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Official title
A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-06-30
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First posted
2024-08-22
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Registry last updated
2025-05-13
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Primary completion date
2026-06-30
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Start date
2024-07-03
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Participants
1,280
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Participant count basis
Estimated
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Planned participants
1,280
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Protocol amendments
5
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Number of sites
99
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Apnimed
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06566820
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ClinicalTrials.gov ID
NCT06566820
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Other
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)

    Timeframe: 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.

  2. Number of Participants With Vital Signs Abnormalities

    Timeframe: 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.

  3. Number of Participants With Concomitant Therapy (Medication or Devices)

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Sleep Disorders Center of AmericaBirmingham, United States
  • The University of Alabama/Institute for Rural Health ResearchTuscaloosa, United States
  • Chandler Clinical TrialsChandler, United States
  • Desert Clinical Reserach, LLC/CCT ResearchMesa, United States
  • Foothills Research Center/CCT ResearchPhoenix, United States
  • Fiel Family and Sports Medicine/CCT ResearchTempe, United States
  • Noble Clinical ResearchTucson, United States
  • Preferred Research Partners, Inc.Little Rock, United States
  • Orange County Research InstituteAnaheim, United States
  • Core Healthcare GroupCerritos, United States
  • Exalt Clinical Research, Inc.Chula Vista, United States
  • Collaborative Neuroscience Research, LLCLos Alamitos, United States
  • Santa Monica Clinical TrialsLos Angeles, United States
  • Empire Clinical ResearchPomona, United States
  • Probe Clinical Research CorporationRiverside, United States
  • Pacific Research NetworkSan Diego, United States
  • TriValley Sleep CenterSan Ramon, United States
  • SDS Clinical Trials, Inc.Santa Ana, United States
  • Providere Research Inc.West Covina, United States
  • Mountain View Clinical Research, Inc.Denver, United States
  • Meris Clinical ResearchBrandon, United States
  • Teradan Clinical TrialsBrandon, United States
  • St. Francis Medical InstituteClearwater, United States
  • Nouvelle Clinical ResearchCutler Bay, United States
  • Arrow Clinical TrialsDaytona Beach, United States

And 74 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)