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
| スポンサー |
リードスポンサー: Apnimed |
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| ソース | Apnimed |
| 簡単な要約 | 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. |
| 詳細な説明 | 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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| 全体的なステータス | Not yet recruiting | ||||||||
| 開始日 | 2021-09-30 | ||||||||
| 完成日 | 2022-04-01 | ||||||||
| 一次完成日 | 2022-04-01 | ||||||||
| 段階 | Phase 2 | ||||||||
| 研究の種類 | Interventional | ||||||||
| 主な結果 |
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| 二次転帰 |
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| 入学 | 260 |
| 状態 | |
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| 介入 |
介入タイプ: Drug 介入名: AD109 (atomoxetine/aroxybutynin) 説明文: Matching (blinded) formulated AD109 oral tablet administered before sleep 介入タイプ: Drug 介入名: Atomoxetine Hydrochloride 説明文: Matching (blinded) formulated atomoxetine oral tablet administered before sleep アームグループラベル: Atomoxetine 介入タイプ: Drug 介入名: Placebo 説明文: Matching (blinded) formulated placebo oral tablet administered before sleep アームグループラベル: Placebo |
| 適格性 |
基準:
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 性別: All 最低年齢: 18 Years 最大年齢: 75 Years 健康なボランティア: No |
| 全体的な連絡先 | 連絡先情報は、研究が被験者を募集している場合にのみ表示されます。 |
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| 確認日 |
2021-06-01 |
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| 責任者 |
タイプ: Sponsor |
| アクセスを拡大しました | No |
| 条件閲覧 | |
| 腕の数 | 5 |
| アームグループ |
ラベル: AD109 Dose 1 タイプ: Experimental 説明文: AD109 Dose 1 ラベル: AD109 Dose 2 タイプ: Experimental 説明文: AD109 Dose 2 ラベル: AD109 Dose 3 タイプ: Experimental 説明文: AD109 Dose 3 ラベル: Atomoxetine タイプ: Active Comparator 説明文: Atomoxetine ラベル: Placebo タイプ: Placebo Comparator 説明文: Placebo |
| 頭字語 | MARIPOSA |
| 患者データ | No |
| 研究デザイン情報 |
割り当て: Randomized 介入モデル: Parallel Assignment 主な目的: Treatment マスキング: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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