Phase II/III Trial-Sildenafil for Sickle Cell Disease-Assoc. Pulm. Hypertension

II/III 期试验-西地那非治疗镰状细胞病-Assoc。

• 批准号: 7657723
• 金额: $ 38.54万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7657723
• 关键词: Phase; II; III; Trial; Sildenafil

This is an effort to screen approximately 1,000 sickle cell disease patients for pulmonary hypertension by echocardiography followed by a double-blinded, randomized, placebo-controlled clinical trial designed to test the effects of 16 weeks of chronic sildenafil therapy on exercise endurance (six minute walk distance) and pulmonary artery pressure in 132 patients age 12 or older with pulmonary hypertension (PH) and sickle cell disease (SCD). The contractor shall serve as a Clinical Site for the Phase II/III Trial of Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension. A Data Coordinating Center (DCC), eight Clinical Sites, and a pharmacy distribution center are being awarded.

这是一种努力，通过超声心动图筛查大约1,000名镰状细胞疾病患者的肺动脉高压，然后是一项双眼，随机，安慰剂对照的临床试验，旨在测试16周慢性西地那非治疗对运动耐力（六分钟步行距离）的影响（六分钟步行距离）和132名患者肺部疾病（肺动脉疾病）的疾病（年龄较高）和老年人（ph）和phsectementions（ph）（ph）和ph）（ph）。承包商应作为西地那非第II/III期试验的临床部位，用于镰状细胞相关的肺动脉高压。正在授予数据协调中心（DCC），八个临床站点和一个药房分配中心。