Crossover Trial of AD109 in Obstructive Sleep Apnea

Completed · Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Key facts

Study ID

NCT04580394

Run by

Apnimed

People needed

60

Starts

2020-10-27

Expected to finish

2021-05-28

Last updated by the study team

2023-01-31

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
• AHI 10 to <20, or AHI ≥20 if meets other PSG criteria

You may not qualify if…

• History of narcolepsy.
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
• CPAP should not be used for at least 2 weeks prior to first study PSG
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Where it is running

• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• Empire Clinical Research — Pomona, California, United States
• Yale University — New Haven, Connecticut, United States
• Teradan Clinical Trials — Brandon, Florida, United States
• Clinical Trials of Florida — Miami, Florida, United States
• The Neurological Center of North Georgia — Gainesville, Georgia, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.