Clinical trial NCT05071612: Parallel Arm Trial of AD109 and AD504 In Patients With OSA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: OSA - Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2021-10-08
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in AHI, combined AD109 dose arms vs. combined placebo arms
timeFrame: 28 Days
Secondary outcomes:
measure: Change in AHI, combined AD504 dose arms vs. combined placebo arms
timeFrame: 28 Days
measure: Change in AHI, combined atomoxetine dose arms vs. combined placebo arms
timeFrame: 28 Days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Santa Monica Clinical Trials
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Colorado Springs
country: United States
facility: Delta Waves
state: Colorado
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America -- Hollywood
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Chevy Chase
country: United States
facility: The Center for Sleep & Wake Disorders
state: Maryland
city: Glen Burnie
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
state: Maryland
city: Newton
country: United States
facility: Neurocare
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Sterling Heights
country: United States
facility: Sleep and Attention Disorders Institute
state: Michigan
city: Woodbury
country: United States
facility: Minnesota Lung Center / Minnesota Sleep Institute
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital Sleep Medicine
state: Missouri
city: Maplewood
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: New York
country: United States
facility: Clinilabs
state: New York
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A.
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Malvern
country: United States
facility: Brian Abaluck, LLC
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants LLC
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
Study officials:
References: