NCT00159887已完成3 期
A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.66 个研究点 分布在 16 个国家目标入组 260 人开始时间: 2002年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 66
- 主要终点
- Safety
研究概览
简要总结
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients with PAH who had completed the 12 week pivotal study
排除标准
- •Any other patients with PAH that had not been included into the pivotal study
结局指标
主要结局
Safety
Standard safety data
Efficacy
BORG Dyspnoea Score
6-Minute Walk Test
WHO Functional Class
Quality of Life SF-36 and EQ-5D
次要结局
未报告次要终点
研究者
研究点 (66)
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