EUCTR2006-000804-18-PT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 894 人开始时间: 2010年1月25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
- 894
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
- •Subject Inclusion Criteria
- •A subject is eligible for inclusion in this study if all of the following criteria apply:
- •1. The subject has remained on study drug and completed all assessments during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302*.
- •2.The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*) due to clinical worsening, completed premature termination assessments prior to discontinuing study drug, and who completed all remaining scheduled study visits AND received placebo during the previous study (TDE-PH-301 or TDE-PH-302*).
- •3. The subject voluntarily gives informed consent to participate in the study.
- •4. The subject, if a female of childbearding potential must agree to continue practicing an acceptable method of birth control as deemed appropriate by the physician or institution (i.e. surgical sterilization, approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, an intrauterine device, abstinence, or partner(s) with a vasectomy).
- •* At present it is not envisaged Study TDE-PH-302 will be conducted in the UK
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject Exclusion Criteria
- •1. The subject permanently discontinued study drug during the previous study (TDE-PH-301 or TDE-PH-302*) due to treatment related adverse events.
- •2. The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*) due to clinical worsening (as defined in those study protocols) and did not undergo premature termination assessments prior to discontinuing study drug, and/or did not complete all remaining study visits through to the final scheduled visit.
- •3. The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*) due to clinical worsening, completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits AND received UT-15C SR during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*).
- •4. The subject must not have developed any concurrent illness or condition during the conduct of the previous study, including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left-sided heart disease, unless their physician feels that entry into this study would not be detrimental to their overall health.
- •* At present it is not envisaged Study TDE-PH-302 will be conducted in the UK
研究者
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