NCT00185315已完成3 期
Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.
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
- Bayer
- 入组人数
- 71
- 主要终点
- Adverse events
研究概览
简要总结
The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.
详细描述
This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
- •Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
- •Negative pregnancy test for females
排除标准
- •Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ventavis (Iloprost, BAYQ6256) (Drug)
结局指标
主要结局
Adverse events
时间窗: Throughout the whole study
次要结局
- Tolerability of treatment(Over a minimum of 24 months)
研究者
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