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: 7706539
• 金额: $ 69.62万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 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 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7706539
• 关键词: Phase; II; III; Trial; Sildenafil

Treatment of Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy (WalkPHaSST) Approximately 1,000 patients with sickle cell disease will be screened for pulmonary hypertension (PH) by echocardiography. 132 subjects, age 12 or older, with mild or moderate to severe PH will be randomized to a double-blinded, randomized, placebo-controlled clinical trial designed to test the effects of 16 weeks of sildenafil therapy on exercise capacity (six minute walk distance) and pulmonary artery pressure. Subjects with moderate to severe PH will undergo right heart catheterization prior to randomization. The contractor serves as a Data Coordinating Center (DCC). Ten Clinical Sites and a pharmacy distribution center have also been awarded.

西地那非治疗肺动脉高压和镰状细胞病(WalkPHaSST) 大约1000名镰状细胞病患者将通过超声心动图进行肺动脉高压(PH)筛查。132名年龄在12岁或以上、患有轻度或中度至重度肺高压的受试者将被随机分成一项双盲、随机、安慰剂对照的临床试验，旨在测试16周的西地那非疗法对运动能力(6分钟步行距离)和肺动脉压的影响。中度到重度PH的受试者在随机分组前将接受右心导管术。承包商充当数据协调中心(DCC)。十个临床站点和一个药房配送中心也获得了奖励。