Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Completed · Phase 2 · Has a placebo group

Conditions studied: OSA - Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05071612

Run by

Apnimed

People needed

294

Starts

2021-11-29

Expected to finish

2022-08-03

Last updated by the study team

2022-12-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Sleep Disorders Centers of the Mid-Atlantic (SDCMA) — Glen Burnie, Maryland, United States
• Neurocare — Newton, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Sleep and Attention Disorders Institute — Sterling Heights, Michigan, United States
• Minnesota Lung Center / Minnesota Sleep Institute — Woodbury, Minnesota, United States
• St. Luke's Hospital Sleep Medicine — Chesterfield, Missouri, United States
• Clayton Sleep Institute — Maplewood, Missouri, United States
• Clinilabs — New York, New York, United States
• Coastal Carolina Health Care, P.A. — New Bern, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Intrepid Research — Cincinnati, Ohio, United States
• Brian Abaluck, LLC — Malvern, Pennsylvania, United States
• Bogan Sleep Consultants LLC — Columbia, South Carolina, United States
• Velocity Clinical Research — Greenville, South Carolina, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States

Full record on ClinicalTrials.gov

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