NCT01387191已完成不适用
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg ・ 1.5mg
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 748
- 主要终点
- The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
研究概览
简要总结
The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;
- Unknown adverse reactions (especially, significant adverse reactions)
- Adverse reaction onset status under practical drug use conditions
- Factors possibly influential on safety
- Factors possibly influential on efficacy
- Patient's prognosis, efficacy and safety in long-term use
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with cardiovascular disease
排除标准
- •Subjects with hypersensitivity to epoprostenol
- •Subjects with right cardiac failure during an acute exacerbation
- •Subjects with severe left ventricular systolic dysfunction
- •Subjects with serious left ventricular dysfunction
- •Subjects whose pulmonary edema getting worse during dose initiation
研究组 & 干预措施
Subjects prescribed epoprostenol
Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period
干预措施: Epoprostenol (Drug)
结局指标
主要结局
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Fosrenol Post-marketing Surveillance in JapanKidney DiseaseHyperphosphatemiaNCT01955876Bayer343
已完成
不适用
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in JapanHyperphosphatemiaNCT01412398Bayer446
已完成
不适用
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without DilutionInfectionNCT01690559Bayer704
已完成
不适用
Fosrenol Post-marketing Surveillance for Hemodialysis in JapanHyperphosphatemiaNCT01419327Bayer3,267
已完成
1 期
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese SubjectsAsthmaNCT01000597GlaxoSmithKline80