A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,280
- 试验地点
- 98
- 主要终点
- Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
研究概览
简要总结
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completion of APC-APN-304 without permanent discontinuation of IMP.
- •Completion of APC-APN-305 without permanent discontinuation of IMP.
排除标准
- •Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.
- •Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.
研究组 & 干预措施
AD109
Open Label AD109
干预措施: Aroxybutynin and Atomoxetine (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
时间窗: through study completion, an average of 1 year
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity.
Number of Participants With Vital Signs Abnormalities
时间窗: through study completion, an average of 1 year
Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.
Number of Participants With Concomitant Therapy (Medication or Devices)
时间窗: through study completion, an average of 1 year
Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.
次要结局
未报告次要终点