Measuring Atomoxetine and Aroxybutynin In Patients With OSA
Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of Atomoxetine/Aroxybutynin (AD109) to Atomoxetine Alone or Placebo in Obstructive Sleep Apnea
| Sponsorer |
Ledande sponsor: Apnimed |
|---|---|
| Källa | Apnimed |
| Kort sammanfattning | MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study of AD109 in participants with OSA. Enrolled participants will be randomized to one of 5 parallel treatment arms. |
| detaljerad beskrivning | MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study in participants with OSA. A screening visit and polysomnograms (PSGs) will be conducted to establish that each participant meets study enrollment criteria. The screening PSGs will serve as the baseline for the PSGs conducted during the 3rd and 4th weeks of drug treatment. Enrolled participants will be randomized to one of 5 parallel treatment arms. The first week of dosing will be with a lower dose run-in of AD109 (or corresponding single-drug component or placebo), followed by the full dose taken in weeks 2-4. One combination tablet is taken each night immediately before lights out. A total of approximately 260 participants will be enrolled. |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Övergripande status | Not yet recruiting | ||||||||
| Start datum | 2021-09-30 | ||||||||
| Slutförelsedatum | 2022-04-01 | ||||||||
| Primärt slutdatum | 2022-04-01 | ||||||||
| Fas | Phase 2 | ||||||||
| Studietyp | Interventional | ||||||||
| Primärt resultat |
|
||||||||
| Sekundärt resultat |
|
||||||||
| Inskrivning | 260 |
| Tillstånd | |
|---|---|
| Intervention |
Interventionstyp: Drug Interventionens namn: AD109 (atomoxetine/aroxybutynin) Beskrivning: Matching (blinded) formulated AD109 oral tablet administered before sleep Interventionstyp: Drug Interventionens namn: Atomoxetine Hydrochloride Beskrivning: Matching (blinded) formulated atomoxetine oral tablet administered before sleep Arm Group-etikett: Atomoxetine Interventionstyp: Drug Interventionens namn: Placebo Beskrivning: Matching (blinded) formulated placebo oral tablet administered before sleep Arm Group-etikett: Placebo |
| Behörighet |
Kriterier:
Inclusion Criteria: - Between 18 to 65 years of age for men and 75 for women, inclusive - AHI between 10 to 45 with <25% events central or mixed apneas - BMI between 18.5 and 38 kg/m2 Exclusion Criteria: - Current clinically significant sleep disorder other than OSA - Clinically significant craniofacial malformation or grade ≥3 tonsillar hypertrophy. - Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 drugs for control (combination drugs count as 1 drug). - Clinically significant neurological disorder, including epilepsy/convulsions. - History of clinically significant urinary retention, gastric retention or other severe decreased gastrointestinal motility condition - Severe or frequent gastroesophageal reflux or constipation - 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 Kön: All Lägsta ålder: 18 Years Högsta ålder: 75 Years Friska volontärer: No |
| Övergripande kontakt | Kontaktinformation visas endast när studien rekryterar försökspersoner. |
|---|
| Verifieringsdatum |
2021-06-01 |
|---|---|
| Ansvarig part |
Typ: Sponsor |
| Har utökad åtkomst | No |
| Villkorssökning | |
| Antal vapen | 5 |
| Arm Group |
Märka: AD109 Dose 1 Typ: Experimental Beskrivning: AD109 Dose 1 Märka: AD109 Dose 2 Typ: Experimental Beskrivning: AD109 Dose 2 Märka: AD109 Dose 3 Typ: Experimental Beskrivning: AD109 Dose 3 Märka: Atomoxetine Typ: Active Comparator Beskrivning: Atomoxetine Märka: Placebo Typ: Placebo Comparator Beskrivning: Placebo |
| Akronym | MARIPOSA |
| Patientdata | No |
| Information om studiedesign |
Tilldelning: Randomized Interventionsmodell: Parallel Assignment Huvudsakliga syfte: Treatment Maskering: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.