临床试验/NCT00882947

NCT00882947已完成不适用

Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

Bayer0 个研究点目标入组 38 人开始时间: 2006年2月最近更新: 2009年4月17日

适应症

干预措施

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Bayer

申办方类型

Industry

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