EUCTR2006-000804-18-FR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
nited Therapeutics Corporation0 个研究点目标入组 450 人开始时间: 2007年1月19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
- •1. Subjects who remained on study drug and completed all assessments during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302*.
- •2. 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, and who are revealed to have received placebo during the previous study (TDE-PH-301 or TDE-PH-302*).
- •* Study TDE-PH-302 not being conducted in the UK
- •Are the trial subjects under 18? no
- •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
- •1. Subjects who did not complete all assessments during the Treatement Phase of Study TDE-PH 301 or TDE-PH-302*.
- •2. 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, and who are revealed to have received active drug during the previous study (TDE-PH-301 or TDE-PH-302*) are not eligible for entry into this study as the subject previously clinically worsened on active drug.
- •3. Subjects who permanently discontinued study drug during the previous study (TDE-PH-301 or TDE-PH-302*) due to treatment related adverse events, even if they completed all remaining study visits in the previous study.
- •* Study TDE-PH-302 is not being conducted in the UK
研究者
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