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
| Спонсоры |
Ведущий спонсор: Apnimed |
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| Источник | Apnimed |
| Краткое содержание | 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. |
| Подробное описание | 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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| Общий статус | Not yet recruiting | ||||||||
| Дата начала | 2021-09-30 | ||||||||
| Дата завершения | 2022-04-01 | ||||||||
| Дата первичного завершения | 2022-04-01 | ||||||||
| Фаза | Phase 2 | ||||||||
| Тип исследования | Interventional | ||||||||
| Первичный результат |
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| Вторичный результат |
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| Регистрация | 260 |
| Состояние | |
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| Вмешательство |
Тип вмешательства: Drug Название вмешательства: AD109 (atomoxetine/aroxybutynin) Описание: Matching (blinded) formulated AD109 oral tablet administered before sleep Тип вмешательства: Drug Название вмешательства: Atomoxetine Hydrochloride Описание: Matching (blinded) formulated atomoxetine oral tablet administered before sleep Этикетка Arm Group: Atomoxetine Тип вмешательства: Drug Название вмешательства: Placebo Описание: Matching (blinded) formulated placebo oral tablet administered before sleep Этикетка Arm Group: Placebo |
| Приемлемость |
Критерии:
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 Пол: All Минимальный возраст: 18 Years Максимальный возраст: 75 Years Здоровые волонтеры: No |
| Общий контакт | Контактная информация отображается только при наборе участников исследования. |
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| Дата проверки |
2021-06-01 |
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| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр | |
| Количество рук | 5 |
| Группа вооружений |
Метка: AD109 Dose 1 Тип: Experimental Описание: AD109 Dose 1 Метка: AD109 Dose 2 Тип: Experimental Описание: AD109 Dose 2 Метка: AD109 Dose 3 Тип: Experimental Описание: AD109 Dose 3 Метка: Atomoxetine Тип: Active Comparator Описание: Atomoxetine Метка: Placebo Тип: Placebo Comparator Описание: Placebo |
| Акроним | MARIPOSA |
| Данные пациента | No |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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