NCT00796510终止3 期
A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously enrolled in B1321001 for at least 4 weeks.
- •Previously enrolled in B1321003, discontinued from the study.
- •Completed the B1321003 study as planned.
排除标准
- •Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
研究组 & 干预措施
Sitaxsentan
Experimental
Monotherapy arm
干预措施: Sitaxsentan (Drug)
Sitaxsentan and Sildenafil
Experimental
Combination treatment
干预措施: Sitaxsentan and Sildenafil (Drug)
结局指标
主要结局
Overall Survival
时间窗: Baseline and every 12 weeks up to Week 18
Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.
次要结局
- Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24(Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18))
- Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)(Baseline, Week 12 and ET (up to Week 18))
研究者
研究点 (1)
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