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
| 스폰서 |
리드 스폰서: Apnimed |
|---|---|
| 출처 | Apnimed |
| 간단한 요약 | 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. |
| 상세 설명 | 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. |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| 전반적인 상태 | Not yet recruiting | ||||||||
| 시작일 | 2021-09-30 | ||||||||
| 완료 날짜 | 2022-04-01 | ||||||||
| 기본 완료 날짜 | 2022-04-01 | ||||||||
| 단계 | Phase 2 | ||||||||
| 연구 유형 | Interventional | ||||||||
| 주요 결과 |
|
||||||||
| 2 차 결과 |
|
||||||||
| 등록 | 260 |
| 질환 | |
|---|---|
| 개입 |
개입 유형: Drug 개입 이름: AD109 (atomoxetine/aroxybutynin) 기술: Matching (blinded) formulated AD109 oral tablet administered before sleep 개입 유형: Drug 개입 이름: Atomoxetine Hydrochloride 기술: Matching (blinded) formulated atomoxetine oral tablet administered before sleep 팔 그룹 레이블: Atomoxetine 개입 유형: Drug 개입 이름: Placebo 기술: Matching (blinded) formulated placebo oral tablet administered before sleep 팔 그룹 레이블: Placebo |
| 적임 |
기준:
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 성별: All 최소 연령: 18 Years 최대 연령: 75 Years 건강한 자원 봉사자: No |
| 전반적인 연락처 | 연락처 정보는 연구가 피험자를 모집하는 경우에만 표시됩니다. |
|---|
| 확인 날짜 |
2021-06-01 |
|---|---|
| 책임있는 당사자 |
유형: Sponsor |
| 확장 된 액세스 있음 | No |
| 조건 찾아보기 | |
| 팔 수 | 5 |
| 팔 그룹 |
상표: AD109 Dose 1 유형: Experimental 기술: AD109 Dose 1 상표: AD109 Dose 2 유형: Experimental 기술: AD109 Dose 2 상표: AD109 Dose 3 유형: Experimental 기술: AD109 Dose 3 상표: Atomoxetine 유형: Active Comparator 기술: Atomoxetine 상표: Placebo 유형: Placebo Comparator 기술: Placebo |
| 두문자어 | MARIPOSA |
| 환자 데이터 | No |
| 연구 설계 정보 |
배당: Randomized 개입 모델: Parallel Assignment 주요 목적: Treatment 마스킹: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.