NCT01470144已完成3 期
An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
Actelion0 个研究点目标入组 41 人开始时间: 2011年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Treatment-emergent Adverse Events
研究概览
简要总结
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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-066A301
- •Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301
排除标准
- •Patients who prematurely discontinued study drug in study AC-066A301
- •Patients for whom continued treatment with EFI is no longer considered appropriate
研究组 & 干预措施
Treatment
Experimental
Single arm, open-label
干预措施: Epoprostenol (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events
时间窗: On average 2.72 years
次要结局
- Exposure Duration(On average 2.72 years)
研究者
相似试验
已完成
4 期
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401Pulmonary Arterial HypertensionNCT01105117Actelion2
进行中（未招募）
不适用
An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)Pulmonary Arterial HypertensionMedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018320-10-NLACTELION Pharmaceuticals Ltd40
进行中（未招募）
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An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)Hipertension Arterial PulmonarMedDRA version: 14.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018320-10-ESACTELION Pharmaceuticals Ltd40
已完成
3 期
An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)10037454Pulmonary arterial hypertensionNL-OMON39075Actelion Pharmaceuticals5
进行中（未招募）
不适用
An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary Arterial HypertensionEUCTR2010-018320-10-BEACTELION Pharmaceuticals Ltd40