EUCTR2006-000804-18-IT进行中（未招募）1 期
An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT
ITED THERAPEUTICS0 个研究点目标入组 450 人开始时间: 2007年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who remained on study drug and completed all assessments during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302 are eligible for this study. Subjects who permanently discontinued study drug during the Treatment Phase of the previous study TDE-PH-301 or TDE-PH-302 due to clinical worsening, who completed premature termination assessments prior to discontinuing study drug, and who completed all remaining scheduled study visits, are eligible for entry into this study. However, if the subject received active drug during the Treatment Phase of the previous study TDE-PH-301 or TDE-PH-302 , then the subject may not participate in this study, as the subject previously clinically worsened on active drug. If the subject received placebo during the Treatment Phase of the previous study, then the subject is eligible for this study and should start treatment UT-15C SR in the open-label study at 1 mg twice daily.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who permanently discontinued study drug during the previous study TDE-PH-301 or TDE-PH-302 due to treatment related adverse events are not eligible for entry into this study, even if they completed all remaining study visits in the previous study. Subjects who permanently discontinued study drug during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302 due to clinical worsening as defined in those study protocols and who did not undergo premature termination assessments prior to discontinuing study drug, and/or who did not complete all remaining study visits through the final scheduled visit, are also not eligible for entry into this study.
研究者
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