NCT01406327已完成不适用
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
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
- 入组人数
- 900
- 主要终点
- The number of adverse events and clinical course in subjects with hepatic dysfunction
研究概览
简要总结
The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;
- Unknown adverse drug reactions (ADRs)
- Incidence of ADRs to medical products in actual clinical practice
- Factors influencing safety of ambrisentan
- Factors influencing efficacy of ambrisentan
- Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must use ambrisentan for the first time
排除标准
- •Subjects with hypersensitivity to ambrisentan
- •Subjects who is pregnant or might be pregnant
- •Subjects with severe hepatic disorder
研究组 & 干预措施
Subjects prescribed ambrisentan
Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
干预措施: Ambrisentan (Drug)
结局指标
主要结局
The number of adverse events and clinical course in subjects with hepatic dysfunction
时间窗: 1 year
The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan
时间窗: 1 year
The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage
时间窗: 1 year
次要结局
未报告次要终点
研究者
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