CLINICAL TRIAL: BOSENTAN IN PATIENTS WITH SYMPTOMATIC PULMONARY HYPERTENSION & S

临床试验：波生坦治疗有症状的肺动脉高压患者

• 批准号: 7716862
• 负责人: Kenneth I Ataga
• 金额: $ 0.02万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716862
• 关键词: Cardiac Catheterization Procedures; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Enrollment; France; Funding; Grant; Institution; Netherlands; Patients; Phase; Placebo Control; Pulmonary Hypertension; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Sickle Cell Anemia; Source; United States National Institutes of Health; bosentan; pulmonary arterial hypertension

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized, placebo-controlled, multicenter, Phase IIIb study designed to assess the safety and efficacy of Bosentan (125 mg BID) in sickle cell disease patients with pulmonary arterial hypertension confirmed by right-heart catheterization. A total of 78 patients will be enrolled. The study will be conducted in approximately 24 centers in the US, the UK, France, and the Netherlands.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项随机、安慰剂对照、多中心、IIIb 期研究，旨在评估波生坦（125 mg BID）对经右心导管插入术证实患有肺动脉高压的镰状细胞病患者的安全性和有效性。 总共将招募 78 名患者。 该研究将在美国、英国、法国和荷兰的大约 24 个中心进行。