NCT01204853终止3 期
A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese 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
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Has a current diagnosis of symptomatic PAH
- •Has 6MWT distances from 150 to 450 meters and distance
排除标准
- •Previous exposure to an endothelin receptor antagonist
- •Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
- •Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.
研究组 & 干预措施
Sitaxentan treatment
Experimental
干预措施: Sitaxentan (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 weeks
Number of participants with any adverse events, severe adverse events, serious adverse events
Change From Baseline in 6-minute Walk Distance
时间窗: 12 weeks
Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.
次要结局
- Change From Baseline in WHO Functional Class(12 weeks)
- Number of Participants With Haemodynamics Parameters(12 weeks)
- Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)(12 weeks)
- Clinical Worsening(12 weeks)
- Number of Participants With Pharmacokinetic (PK) Parameters at Steady State(pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsHypertension, PulmonaryNCT01210443Pfizer2
已完成
1 期
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western SubjectsHealthyNCT00981968Pfizer22
已完成
3 期
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionNCT00080457Encysive Pharmaceuticals240
已完成
3 期
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%Primary ImmunodeficiencyNCT02269163Prometic Biotherapeutics, Inc.82
已完成
3 期
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of ObesityBardet-Biedl SyndromePOMC Deficiency ObesityPCSK1 Deficiency ObesityLEPR Deficiency ObesityNCT04966741Rhythm Pharmaceuticals, Inc.12