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This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD109 | Experimental | AD109 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD109 | Drug | Oral administration at bedtime |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Apnea-Hypopnea Index (AHI) | AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology & Sleep Medicine | Tuscaloosa | Alabama | 35406 | United States | ||
| Desert Clinical Research - CCT Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42148495 | Derived | Strollo PJ Jr, Farkas R, Taranto-Montemurro L, Cronin J, Patel SR; SynAIRgy Investigators. Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy). Am J Respir Crit Care Med. 2026 May 18:aamag215. doi: 10.1093/ajrccm/aamag215. Online ahead of print. |
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| Drug |
Oral administration at bedtime |
|
| Mesa |
| Arizona |
| 85213 |
| United States |
| Foothills Research Center - CCT Research | Phoenix | Arizona | 85044 | United States |
| Fiel Family Sports Medicine - PC CCT Research | Tempe | Arizona | 85283 | United States |
| Noble Clinical Research | Tucson | Arizona | 85704 | United States |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | United States |
| Orange County Research Institute | Anaheim | California | 92801 | United States |
| North County Neurology Associates | Carlsbad | California | 92011 | United States |
| Core Healthcare Group | Cerritos | California | 90703 | United States |
| Exalt Clinical Research | Chula Vista | California | 91910 | United States |
| Catalina Research Institute | Montclair | California | 91763 | United States |
| Probe Clinical Research Corporation | Riverside | California | 92501 | United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | United States |
| SDS Clinical Trials Inc. | Santa Ana | California | 92705 | United States |
| Provideré Research Inc. | West Covina | California | 91790 | United States |
| Meris Clinical Research | Brandon | Florida | 33511 | United States |
| Nouvelle Clinical Research | Cutler Bay | Florida | 33189 | United States |
| Accel Research Sites | DeLand | Florida | 32720 | United States |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States |
| Canvas Clinical Research | Lake Worth | Florida | 33467 | United States |
| Florida Lung and Sleep Associates | Lehigh Acres | Florida | 33971 | United States |
| Advanced Medical Research Institute | Miami | Florida | 33174 | United States |
| Clinical Site Partners | Miami | Florida | 33186 | United States |
| Clinical Neuroscience Solutions, Inc - Orlando | Orlando | Florida | 32801 | United States |
| JSV Clinical Research Study Inc | Tampa | Florida | 33634 | United States |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | United States |
| Atlanta Center for Medical Research, LLC | Atlanta | Georgia | 30031 | United States |
| NeuroTrials Research | Atlanta | Georgia | 30342 | United States |
| Georgia Neurology and Sleep Medicine Assoc | Suwanee | Georgia | 30024 | United States |
| Javarra Inc-Privia Medical Group | Thomasville | Georgia | 31792 | United States |
| St. Lukes Clinic - Idaho Pulmonary Associates | Meridian | Idaho | 83642 | United States |
| Chicago Research Center Inc | Chicago | Illinois | 60634 | United States |
| OSF HealthCare Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40220 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Infinity Medical Research | North Dartmouth | Massachusetts | 02747 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Revive Research Institute | Lathrup Village | Michigan | 48076 | United States |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | United States |
| Neurology Specialists of Monmouth County | West Long Branch | New Jersey | 07764 | United States |
| Javara Inc - Tryon Medical Partners PLCC | Charlotte | North Carolina | 28210 | United States |
| Research Carolina Elite | Denver | North Carolina | 28025 | United States |
| Peters Medical Research, LLC | High Point | North Carolina | 27260 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Sleep Management Institute (Intrepid) | Cincinnati | Ohio | 45245 | United States |
| UC Health Sleep Medicine | Cincinnati | Ohio | 45267 | United States |
| University Hospital of Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Abington Neurological Associate | Abington | Pennsylvania | 19001 | United States |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | United States |
| Tribe Clinical Research LL | Greenville | South Carolina | 29607 | United States |
| OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A | Rock Hill | South Carolina | 29732 | United States |
| Chattanooga Research & Medicine, PLLC | Chattanooga | Tennessee | 37404 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| The Heights Hospital (HD Heights) | Houston | Texas | 77008 | United States |
| Weill Cornell Medical College | Houston | Texas | 77030 | United States |
| Lone Star Lung and Sleep Clinic | Houston | Texas | 77070 | United States |
| Huntsville Research Institute LLC | Huntsville | Texas | 77340 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| Element Research Group | San Antonio | Texas | 78229 | United States |
| South Ogden Family Medicine / CCT Research | South Ogden | Utah | 84405 | United States |
| Canadian Sleep Consultants | Calgary | Alberta | T2Z 3R6 | Canada |
| Medical Arts Health Research | Kelowna | British Columbia | V1Y 9N7 | Canada |
| AMNDX | Markham | Ontario | L3R 1A3 | Canada |
| West Ottawa Sleep Centre | Ottawa | Ontario | K2C 0P7 | Canada |
| Canadian Phase Onward Inc. | Toronto | Ontario | M3J 0K2 | Canada |
| Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
| Sleep and Alertness Center | Toronto | Ontario | M5S 3A3 | Canada |
| McGill University Health Centre | Montreal | Quebec | QC H4A | Canada |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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