A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
研究概览
简要总结
This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).
详细描述
Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure.
Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial
排除标准
- 未提供
研究组 & 干预措施
Udenafil
Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks)
干预措施: Udenafil (Drug)
结局指标
主要结局
Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
时间窗: during 48-weeks
Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc
次要结局
- Echocardiography(48-week)
- Time to clinical worsening(TTCW)(during 48-weeks)
- 6-MWD(24, 48-week)
- NT-pro BNP(24, 48-week)
- BORG dyspnea score(24, 48-week)
- WHO class(12, 24, 36, 48-week)