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

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:
8328355
负责人:
JANE LITTLE
金额:
$1.31万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-09-30 至 2011-06-30

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中文摘要
翻译
这是一项通过超声心动图筛查约1000名镰状细胞病患者肺动脉高压的努力,随后是一项双盲、随机、安慰剂对照临床试验,旨在测试16周慢性西地那非治疗对132名12岁或以上肺动脉高压(PH)和镰状细胞病(SCD)患者运动耐力(6分钟步行距离)和肺动脉压的影响。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期试验的临床站点。正在授予1个数据协调中心、8个临床站点和1个药品配送中心。
英文摘要
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.
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SILDENAFIL FOR SICKLE CELL DISEASE-ASSOCIATED PULMONARY HYPERTENSION
  • 批准号:
    7542893
  • 项目类别:
  • 资助金额:
    $47.12万
  • 财政年份:
    2006
  • 负责人:
    JANE LITTLE
  • 依托单位:
    --
Phase II/III Trial-Sildenafil for Sickle Cell Disease-Assoc. Pulm. Hypertension
  • 批准号:
    8014335
  • 项目类别:
  • 资助金额:
    $7.95万
  • 财政年份:
    2006
  • 负责人:
    JANE LITTLE
  • 依托单位:
海外基金