Phase 2, Placebo-Controlled, Parallel Group Dose-Finding Study to Evaluate the Efficacy and Safety of Three Dose Levels of AD036 in Adults With Obstructive Sleep Apnea
Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 70
Healthy Volunteers: f
View:
• AHI ≥ 20 based on screening polysomnography
• Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
• Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment
Locations
United States
Arkansas
Preferred Research Partners, Inc.
Little Rock
Arizona
Pulmonary Associates
Glendale
California
Stanford Sleep Medicine
Redwood City
SDS Clinical Trials, Inc.
Santa Ana
Santa Monica Clinical Trials
Santa Monica
Illinois
Northwestern University
Chicago
Kentucky
Norton Clinical Research Group
Louisville
Maryland
The Center for Sleep and Wake Disorders
Chevy Chase
Missouri
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield
New York
Clinilabs Drug Development Corporation
New York
Ohio
CTI Clinical Research Center
Cincinnati
Texas
Sleep Therapy & Research Center
San Antonio
Time Frame
Start Date: 2019-03-07
Completion Date: 2019-10-23
Participants
Target number of participants: 140
Treatments
Placebo_comparator: 2-Night at Home
An initial 2-night, at-home blinded baseline period in which all subjects received placebo
Experimental: 3-Night Run In
AD036 Dose 1 (Low Dose: 25/5) or Placebo
Experimental: 7-Night
A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo
No_intervention: End of Study
End of Study Visit
Authors
Paula K Schweitzer, James P Maynard, Mark Gotfried, Phyllis Zee, Andrew O Schreiber, Paul E Wylie, Mardik Donikyan, Daniel Norman, Helene Emsellem
Related Therapeutic Areas
Sponsors
Leads: Apnimed