NCT01066845已完成不适用
Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan
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
- 1,809
- 主要终点
- The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
研究概览
简要总结
To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-
- To evaluate the incidence of adverse events for the patients with long-term use
- To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PAH receiving Adcirca
排除标准
- •Patients who meet the criteria of contraindication
- •patients with hypersensitivity to tadalafil
- •patients who are using any form of organic nitrate
- •patients with severe renal impairment
- •patients with severe hepatic impairment
- •patients taking strong inhibitors of CYP3A4
- •patients taking strong inducers of CYP3A4
研究组 & 干预措施
Patients prescribed Adcirca
all patients prescribed Adcirca during study period
干预措施: tadalafil (Drug)
结局指标
主要结局
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
时间窗: 2 years
次要结局
- 6 minute walk distance change from baseline(2 years)
- World Health Organization (WHO) functional class change from baseline(2 years)
- Survival time(2 years)
- Pulmonary arterial pressure change from baseline(2 years)
- Score change of Euro Quality of Life (EQ-5D) from baseline(2 years)
研究者
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