RBR-9q7dy5招募中3 期
An open-label extension study of UT-15C in subjects with pulmonary arterial hypertension - a long-term follow-up toprotocol TDE-PH-310
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA0 个研究点开始时间: 2014年12月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 75Y（—）
入选标准
- •Patients who participated in the study TDE-PH-310 and met the definition of clinical worsening (as specified in the protocol TDE-PH-310), continued treatment with study drug, was compliant with assessments and study procedures during TDE-PH-310 or were enrolled in that study when it was discontinued by the sponsor. Women of childbearing potential must be on real abstinent or use two highly effective contraceptive methods throughout the study and for at least 30 days after discontinuation of study medication. Men participating in the study should use condoms throughout the study and for at least 48 hours after the last dose of study medication.
排除标准
- •Pregnant or breastfeeding female patient. Patient receiving therapy with prostacyclin by infusion or inhalation. Patient who was early withdrawn from the study TDE-PH-310 due to reasons other than the event of clinical worsening. Patient developed a concomitant disease or condition during participation in the original study TDE-PH-310, which in the opinion of the study physician, would represent a risk to the general health if the patient were enrolled in this extension study.
研究者
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