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
| Sponsor |
Lead Sponsor: Apnimed |
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| Fonte | Apnimed |
| Breve riassunto | 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. |
| Descrizione dettagliata | 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. |
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| Stato generale | Not yet recruiting | ||||||||
| Data d'inizio | 2021-09-30 | ||||||||
| Data di completamento | 2022-04-01 | ||||||||
| Data di completamento principale | 2022-04-01 | ||||||||
| Fase | Phase 2 | ||||||||
| Tipo di studio | Interventional | ||||||||
| Il risultato principale |
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| Esito secondario |
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| Iscrizione | 260 |
| Condizione | |
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| Intervento |
Tipo di intervento: Drug Nome intervento: AD109 (atomoxetine/aroxybutynin) Descrizione: Matching (blinded) formulated AD109 oral tablet administered before sleep Tipo di intervento: Drug Nome intervento: Atomoxetine Hydrochloride Descrizione: Matching (blinded) formulated atomoxetine oral tablet administered before sleep Etichetta del gruppo del braccio: Atomoxetine Tipo di intervento: Drug Nome intervento: Placebo Descrizione: Matching (blinded) formulated placebo oral tablet administered before sleep Etichetta del gruppo del braccio: Placebo |
| Eleggibilità |
Criteri:
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 Genere: All Età minima: 18 Years Età massima: 75 Years Volontari sani: No |
| Contatto generale | Le informazioni di contatto vengono visualizzate solo quando lo studio sta reclutando soggetti. |
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| Data di verifica |
2021-06-01 |
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| Parte responsabile |
Genere: Sponsor |
| Ha accesso esteso | No |
| Condizione Sfoglia | |
| Numero di armi | 5 |
| Braccio di gruppo |
Etichetta: AD109 Dose 1 Genere: Experimental Descrizione: AD109 Dose 1 Etichetta: AD109 Dose 2 Genere: Experimental Descrizione: AD109 Dose 2 Etichetta: AD109 Dose 3 Genere: Experimental Descrizione: AD109 Dose 3 Etichetta: Atomoxetine Genere: Active Comparator Descrizione: Atomoxetine Etichetta: Placebo Genere: Placebo Comparator Descrizione: Placebo |
| Acronimo | MARIPOSA |
| Dati del paziente | No |
| Informazioni sul design dello studio |
Assegnazione: Randomized Modello di intervento: Parallel Assignment Scopo principale: Treatment Mascheramento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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