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
| Sponsorit |
Johtava sponsori: Apnimed |
|---|---|
| Lähde | Apnimed |
| Lyhyt yhteenveto | 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. |
| Yksityiskohtainen kuvaus | 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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| Yleinen tila | Not yet recruiting | ||||||||
| Aloituspäivämäärä | 2021-09-30 | ||||||||
| Valmistumispäivä | 2022-04-01 | ||||||||
| Ensisijainen valmistumispäivä | 2022-04-01 | ||||||||
| Vaihe | Phase 2 | ||||||||
| Tutkimuksen tyyppi | Interventional | ||||||||
| Ensisijainen tulos |
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| Toissijainen tulos |
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| Ilmoittautuminen | 260 |
| Kunto | |
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| Interventio |
Interventiotyyppi: Drug Intervention nimi: AD109 (atomoxetine/aroxybutynin) Kuvaus: Matching (blinded) formulated AD109 oral tablet administered before sleep Interventiotyyppi: Drug Intervention nimi: Atomoxetine Hydrochloride Kuvaus: Matching (blinded) formulated atomoxetine oral tablet administered before sleep Varren ryhmän etiketti: Atomoxetine Interventiotyyppi: Drug Intervention nimi: Placebo Kuvaus: Matching (blinded) formulated placebo oral tablet administered before sleep Varren ryhmän etiketti: Placebo |
| Tukikelpoisuus |
Kriteeri:
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 Sukupuoli: All Vähimmäisikä: 18 Years Enimmäisikä: 75 Years Terveet vapaaehtoiset: No |
| Yleinen yhteyshenkilö | Yhteystiedot näkyvät vain, kun tutkimukseen rekrytoidaan kohteita. |
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| Vahvistuspäivä |
2021-06-01 |
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| Vastuullinen osapuoli |
Tyyppi: Sponsor |
| On laajentanut käyttöoikeuksia | No |
| Ehto Selaa | |
| Aseiden lukumäärä | 5 |
| Arm-ryhmä |
Tarra: AD109 Dose 1 Tyyppi: Experimental Kuvaus: AD109 Dose 1 Tarra: AD109 Dose 2 Tyyppi: Experimental Kuvaus: AD109 Dose 2 Tarra: AD109 Dose 3 Tyyppi: Experimental Kuvaus: AD109 Dose 3 Tarra: Atomoxetine Tyyppi: Active Comparator Kuvaus: Atomoxetine Tarra: Placebo Tyyppi: Placebo Comparator Kuvaus: Placebo |
| Lyhenne | MARIPOSA |
| Potilastiedot | No |
| Tutkimuksen suunnittelutiedot |
Jakaminen: Randomized Interventiomalli: Parallel Assignment Päätarkoitus: Treatment Naamiointi: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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