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
| 赞助商 |
首席赞助商: Apnimed |
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| 资源 | Apnimed |
| 简要总结 | 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. |
| 详细说明 | 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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| 总体状况 | Not yet recruiting | ||||||||
| 开始日期 | 2021-09-30 | ||||||||
| 完成日期 | 2022-04-01 | ||||||||
| 主要完成日期 | 2022-04-01 | ||||||||
| 相 | Phase 2 | ||||||||
| 研究类型 | Interventional | ||||||||
| 主要结果 |
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| 次要结果 |
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| 注册 | 260 |
| 健康）状况 | |
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| 介入 |
干预类型: Drug 干预名称: AD109 (atomoxetine/aroxybutynin) 描述: Matching (blinded) formulated AD109 oral tablet administered before sleep 干预类型: Drug 干预名称: Atomoxetine Hydrochloride 描述: Matching (blinded) formulated atomoxetine oral tablet administered before sleep 手臂组标签: Atomoxetine 干预类型: Drug 干预名称: Placebo 描述: Matching (blinded) formulated placebo oral tablet administered before sleep 手臂组标签: Placebo |
| 合格 |
标准:
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 性别: All 最低年龄: 18 Years 最高年龄: 75 Years 健康志愿者: No |
| 总体联系方式 | 联系信息仅在研究招募受试者时显示。 |
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| 验证日期 |
2021-06-01 |
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| 责任方 |
类型: Sponsor |
| 扩大了访问范围 | No |
| 条件浏览 | |
| 臂数 | 5 |
| 臂组 |
标签: AD109 Dose 1 类型: Experimental 描述: AD109 Dose 1 标签: AD109 Dose 2 类型: Experimental 描述: AD109 Dose 2 标签: AD109 Dose 3 类型: Experimental 描述: AD109 Dose 3 标签: Atomoxetine 类型: Active Comparator 描述: Atomoxetine 标签: Placebo 类型: Placebo Comparator 描述: Placebo |
| 首字母缩写 | MARIPOSA |
| 患者资料 | No |
| 研究设计信息 |
分配: Randomized 干预模式: Parallel Assignment 首要目标: Treatment 掩蔽: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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