Continuation Protocol for Obstructive Sleep Apnea (OSA)

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)

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1,280 participants in 1 patient group

AD109

Experimental group

Description:

Open Label AD109

Treatment:

Drug: Aroxybutynin and Atomoxetine