CTRI/2014/10/005123已完成3 期
An Open â?? Label Extension study of UT-15C in subjects with Pulmonary Arterial Hypertension â?? A Long-Term Follow-Up to Protocol TDE-PH-310.
nited Therapeutics Corporation0 个研究点目标入组 31 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participated in United Therapeutics Study TDE-PH-310.
- •1.The subject voluntarily provides informed consent to participate in the study.
- •The subject participated in study TDE-PH-310 and met the definition of clinical worsening (as specified in protocol TDE-PH-310), remained on study drug, was compliant with study procedures and assessments during the TDE-PH-310 study or was currently enrolled in that study at the time the study was discontinued by the sponsor.
- •3.Women of childbearing potential (WOCBP) must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. For women of childbearing potential, a negative urine pregnancy test is required at Baseline (study entry) prior to initiating study medication. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea for at least 12 consecutive months].
- •Males participating in the study must use a condom during the length of the study, and for at least 48 hours after their last dose of study medication.
排除标准
- •A subject is not eligible to participate in this study if any of the following criteria apply:
- •1. The subject is pregnant or lactating.
- •2.The subject has received infused or inhaled prostacyclin therapy for 29 days or more.
- •3.The subject was prematurely discontinued from study TDE-PH-310 for reasons other than a clinical worsening event.
- •4.The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.
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