A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects aged 18 and over who have any of the following conditions:
- •Idiopathic pulmonary arterial hypertension.
- •PAH associated with connective tissue disease (CTD).
- •PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
- •Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization.
- •Subjects whose baseline 6-min walk test distance was > 100m and < 450m.
排除标准
- •PAH secondary to any etiology other than those specified in the inclusion criteria.
- •Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure.
- •Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.
结局指标
主要结局
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 116 Weeks
Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.
次要结局
未报告次要终点