NCT01094067终止2 期
Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg
研究概览
简要总结
Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2
Experimental
Tezosentan at visit 1, placebo at visit 2
干预措施: Placebo (Other)
1
Experimental
Placebo at visit 1, tezosentan at visit 2
干预措施: ACT-050089 (Drug)
1
Experimental
Placebo at visit 1, tezosentan at visit 2
干预措施: Placebo (Other)
2
Experimental
Tezosentan at visit 1, placebo at visit 2
干预措施: ACT-050089 (Drug)
结局指标
主要结局
Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg
时间窗: 30 days
次要结局
- Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm(30 days)
研究者
研究点 (5)
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