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: 8109559
• 负责人: Victor R Gordeuk
• 金额: $ 7.68万
• 依托单位: HOWARD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8109559
• 关键词: Age; Award; Chronic; Clinical Trials Design; Contractor; Controlled Clinical Trials; Data Coordinating Center; Double-Blind Method; Echocardiography; Enrollment; Exercise; Hypertension; Patients; Pharmacy Distributions; Phase II/III Trial; Placebo Control; Pulmonary Hypertension; Pulmonary artery structure; Randomized; Sickle Cell Anemia; Testing; Walking; clinical research site; pressure; 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.

这是一项通过超声心动图筛查约1,000名镰状细胞病患者肺动脉高压的努力，安慰剂对照临床试验，旨在测试16周长期西地那非治疗对运动耐力的影响（6分钟步行距离）和肺动脉压在132例12岁或以上的肺动脉高压（PH）和镰状细胞病（SCD）患者。承包商应作为西地那非治疗镰状细胞病相关肺动脉高压II/III期试验的临床研究中心。一个数据协调中心（DCC），八个临床站点和一个药房配送中心将被授予。