NCT00882947已完成不适用
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 38
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Both male and female age 18-65 years old
- •The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- •Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
- •Written informed/data protection consent
- •No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.
排除标准
- •Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.
研究组 & 干预措施
Group 1
干预措施: Ventavis (Iloprost, BAYQ6256) (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: At week 4,12 and 24
次要结局
- 6 minute walking test (6-MWT)(At week 4,12 and 24)
- NYHA functional class(At week 4,12 and 24)
研究者
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