临床试验/NCT01210443

NCT01210443终止3 期

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Pfizer1 个研究点分布在 1 个国家目标入组 2 人开始时间: 2010年11月最近更新: 2011年12月14日

适应症

干预措施

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 long-term 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

•Subject who completed the B1321052 study as planned.

排除标准

•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: Up to 22 days (last participant discontinuation)

Number of participants with any adverse events, severe adverse events, serious adverse events

次要结局

Percentage of Participants With Clinical Worsening(Up to 22 days (last participant discontinuation))
Change From Baseline in 6-Minute Walk Distance(Up to 22 days (last participant discontinuation))
Percentage of Participants With Change From Baseline in WHO Functional Class(Up to 22 days (last participant discontinuation))
Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)(Up to 22 days (last participant discontinuation))

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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