An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 7
- 主要终点
- Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment
研究概览
简要总结
This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study-mandated procedure
- •Patients who completed participation in study AC-066A401
- •Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401
排除标准
- •Patients who prematurely discontinued study drug in study AC-066A401
- •Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate
- •Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
- •Known concomitant life-threatening disease with a life expectancy < 12 months
研究组 & 干预措施
1
ACT-385781A (Actelion Epoprostenol)
干预措施: ACT-385781A (Actelion Epoprostenol) (Drug)
2
Flolan®
干预措施: Flolan® (Drug)
结局指标
主要结局
Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment
时间窗: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths
时间窗: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
次要结局
未报告次要终点