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The trial is taking place at:
A

Advanced Medical Research Institute | Miami, FL

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Continuation Protocol for Obstructive Sleep Apnea (OSA)

Apnimed logo

Apnimed

Status and phase

Invitation-only
Phase 3

Conditions

OSA

Treatments

Drug: Aroxybutynin and Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06566820
APC-APN-306

Details and patient eligibility

About

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.

Enrollment

1,280 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,280 participants in 1 patient group

AD109
Experimental group
Description:
Open Label AD109
Treatment:
Drug: Aroxybutynin and Atomoxetine

Trial contacts and locations

27

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Central trial contact

Ron Farkas, MD; Luigi Taranto, MD, MD

Data sourced from clinicaltrials.gov

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