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临床试验/NCT00046319
NCT00046319已完成2 期

A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension

Gilead Sciences40 个研究点 分布在 6 个国家目标入组 60 人开始时间: 2002年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
40
主要终点
Change from baseline to Week 12 in six minute walk distance

研究概览

简要总结

The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to exercise.

详细描述

This is a randomized, double-blind study evaluating the effectiveness of BSF 208075 in treating patients with moderate to severe pulmonary hypertension. A four-week Screening Period will be followed by 12 weeks of Treatment. After a subject qualifies for the study, the subject will be randomized to one of four doses of BSF 208075 (1.0, 2.5, 5.0 or 10.0 mg po qd). Subjects randomized to the 1.0 or 2.5 mg dose groups will receive their respective doses of BSF 208075 each day throughout the 12-week Treatment Period. Subjects in the two other dose groups will begin treatment at 2.5 mg per day for two weeks and then their dose will be increased to 5.0 mg for an additional two weeks. After two weeks of treatment at 5.0 mg, subjects randomized to the 10.0 mg dose group will undergo a final up-titration. After reaching the randomized dose level, subjects will receive their assigned dose throughout the Treatment Period. Subjects will remain on the randomized treatment through Week 12. In the event that a subject is not tolerating study drug, dose adjustment is permitted during the Treatment Period. Upon completion of the 12-week Treatment Period subjects will either complete a four-week Down-titration Period or enter an optional 12-week Open-label Extension. All subjects that choose to participate in the Open-label Extension will be unblinded and have their dose of BSF 208075 optimized based on the subjects response during the Treatment Period.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline to Week 12 in six minute walk distance

次要结局

  • Change from baseline to Week 12 in:
  • Borg Dyspnea Index
  • WHO Functional Classification
  • Subject Global Assessment

研究者

申办方类型
Industry

研究点 (40)

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