Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Phase 2

Completed

• Conditions: OSA - Obstructive Sleep Apnea
• Interventions: Drug: AD109; Drug: Atomoxetine Hydrochloride; Drug: Placebo; Drug: AD504

• Registration Number: NCT05071612
• Lead Sponsor: Apnimed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Study Start: 2021-11-29
• Primary Completion: 2022-07-20
• Study Completion: 2022-08-03
• Disposition First Submitted: 2022-11-30
• Status Verified: 2022-12
• Disposition First Submitted QC: 2022-12-05
• Last Update Submitted: 2022-12-05
• Disposition First Posted: 2022-12-12
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD109 Dose 2	AD109	-
AD109 Dose 1	AD109	-
Atomoxetine 1	Atomoxetine Hydrochloride	-
Atomoxetine 2	Atomoxetine Hydrochloride	-
Placebo 2	Placebo	-
AD504 Dose 1	AD504	-
Placebo 1	Placebo	-
AD504 Dose 2	AD504	-

Primary Outcome Measures

Name	Time	Method
Change in AHI, combined AD109 dose arms vs. combined placebo arms	28 Days	Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
Change in AHI, combined AD504 dose arms vs. combined placebo arms	28 Days	Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Change in AHI, combined atomoxetine dose arms vs. combined placebo arms	28 Days	Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography

Trial Locations

Locations (25)

Santa Monica Clinical Trials; 🇺🇸 Los Angeles, California, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

SDS Clinical Trials, Inc.; 🇺🇸 Santa Ana, California, United States

Delta Waves; 🇺🇸 Colorado Springs, Colorado, United States

Teradan Clinical Trials; 🇺🇸 Brandon, Florida, United States

Research Centers of America -- Hollywood; 🇺🇸 Hollywood, Florida, United States

Sleep Medicine Specialists of South Florida; 🇺🇸 Miami, Florida, United States

NeuroTrials Research, Inc.; 🇺🇸 Atlanta, Georgia, United States

Chicago Research Center; 🇺🇸 Chicago, Illinois, United States

The Center for Sleep & Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Scroll for more (15 remaining)