NCT00323297已完成4 期
A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.30 个研究点 分布在 10 个国家目标入组 105 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 30
- 主要终点
- Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
研究概览
简要总结
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 above with PAH and for which bosentan therapy is indicated according to national license
- •Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge pressure of <15mmHg at rest via right heart catheterization within 3 years prior to randomization.
- •Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.
排除标准
- •PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
- •Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Bosentan (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Other)
Active
Experimental
干预措施: Bosentan (Drug)
Active
Experimental
干预措施: Sildenafil Citrate (Drug)
结局指标
主要结局
Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
时间窗: Week 12
6MWT is 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.
次要结局
- One Year Survival From the Start of Sildenafil Treatment.(One year from the time of starting sildenafil)
- Clinical Worsening Events(Week 12)
- Change From Baseline in Borg Dyspnea Score at Week 12(Week 12)
- Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF(Week 12)
- One Year Survival Probability From the Start of Sildenafil Treatment.(One year from the time of starting sildenafil)
研究者
研究点 (30)
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