Parallel Arm Trial of AD109 and AD504 In Patients With OSA (MARIPOSA)

Apnimed

Status and phase: Completed; Phase 2

Conditions: OSA - Obstructive Sleep Apnea

Treatments: Drug: AD504; Drug: AD109; Drug: Atomoxetine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05071612

MARIPOSA

Details and patient eligibility

About

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Enrollment: 294 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
• Mean AHI 10 to 45 events/h, inclusive
• PGI-S: >1

Exclusion criteria

• Current clinically significant sleep disorder other than OSA
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
• Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 8 patient groups, including a placebo group

AD109 Dose 1

Experimental group

Treatment:

Drug: AD109

AD109 Dose 2

Experimental group

Treatment:

Drug: AD109

AD504 Dose 1

Experimental group

Treatment:

Drug: AD504

AD504 Dose 2

Experimental group

Treatment:

Drug: AD504

Atomoxetine 1

Active Comparator group

Treatment:

Drug: Atomoxetine Hydrochloride

Atomoxetine 2

Active Comparator group

Treatment:

Drug: Atomoxetine Hydrochloride

Placebo 1

Placebo Comparator group

Treatment:

Drug: Placebo

Placebo 2

Placebo Comparator group

Treatment:

Drug: Placebo