NCT00795639终止3 期
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium 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
- 183
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12
研究概览
简要总结
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.
排除标准
- •Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
研究组 & 干预措施
Sitaxsentan
Experimental
Monotherapy
干预措施: Sitaxsentan (Drug)
Sitaxsentan Placebo
Placebo Comparator
Monotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12
时间窗: Baseline/Day 1 and Week 12
6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.
次要结局
- Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12(Baseline, Weeks 4, 8 and 12 or Early Termination (ET))
- Time to Clinical Worsening (TTCW)(Baseline, Weeks 4, 8 and 12 or ET)
研究者
研究点 (1)
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