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This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD113 | Experimental | Two oral capsules administered before bed |
|
| Atomoxetine | Experimental | Two oral capsules administered before bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD113 | Drug | Two oral capsules administered before bed |
| |
| Atomoxetine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve) | Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine | 10 days of treatment per crossover arm |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) | Change in AHI for AD113 vs. atomoxetine measured by polysomnography | 10 days of treatment per crossover arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PCCAB | Towson | Maryland | 21286 | United States | ||
| Intrepid Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39305436 | Derived | Schwartz AR, Herpel L, Bogan R, Corser B, Pho H, Taranto-Montemurro L. Atomoxetine and spironolactone combine to reduce obstructive sleep apnea severity and blood pressure in hypertensive patients. Sleep Breath. 2024 Dec;28(6):2571-2580. doi: 10.1007/s11325-024-03113-1. Epub 2024 Sep 21. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
Two oral capsules administered before bed |
|
| Cincinnati |
| Ohio |
| 45245 |
| United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |