EUCTR2006-000804-18-AT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 900 人开始时间: 2007年1月17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
- 900
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 the previous study (TDE-PH-301, TDE-PH-302* or TDE-PH-308).
- •The subject permanently discontinued study drug during the Treatment
- •Phase of the previous study (TDE-PH-301, TDE-PH-302* or TDE-PH-308) due to clinical
- •worsening, completed premature termination assessments prior to discontinuing
- •study drug, completed all remaining scheduled study visits AND received
- •placebo during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302* or TDE-PH-308).
- •2. The subject voluntarily gives informed consent to participate in the study.
- •3. The subject, if a female of childbearing 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 a condom or diaphragm] used with a
- •spermicide, an intrauterine device, abstinence, or partner(s) with a vasectomy).
- •[* At present it is not envisaged that Study TDE-PH-302 will be conducted in Ireland]
- •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) 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, TDE-PH-302*or TDE-PH-308) due to treatment related adverse events.
- •2. The subject permanently discontinued study drug during the Treatment
- •Phase of the previous study (TDE-PH-301, TDE-PH-302* or TDE-PH-308) 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 the final scheduled visit.
- •3. The subject permanently discontinued study drug during the Treatment
- •Phase of the previous study (TDE-PH-301, TDE-PH-302* or TDE-PH-308) 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, TDE-PH-302* or TDE-PH-308).
- •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 that Study TDE-PH-302 will be conducted in Ireland]
研究者
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