Phase II/III Trial-Sildenafil for Sickle Cell Disease-Assoc. Pulm. Hypertension
Phase II/III Trial-Sildenafil for Sickle Cell Disease-Assoc. Pulm. Hypertension
批准号:
8014335
负责人:
JANE LITTLE
金额:
$7.95万
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 2010-12-31
关键词:
AgeAwardChronicClinical Trials DesignContractorControlled Clinical TrialsData Coordinating CenterDouble-Blind MethodEchocardiographyEnrollmentExerciseHypertensionPatientsPharmacy DistributionsPhase II/III TrialPlacebo ControlPulmonary HypertensionPulmonary artery structureRandomizedSickle Cell AnemiaTestingWalkingclinical research sitepressuresildenafil
中文摘要
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。
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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Phase II/III Trial-Sildenafil for Sickle Cell Disease-Assoc. Pulm. Hypertension
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批准号:8328355
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项目类别:
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资助金额:$1.31万
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财政年份:2006
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负责人:JANE LITTLE
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依托单位:
SILDENAFIL FOR SICKLE CELL DISEASE-ASSOCIATED PULMONARY HYPERTENSION
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批准号:7542893
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项目类别:
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资助金额:$47.12万
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财政年份:2006
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负责人:JANE LITTLE
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依托单位:--
海外基金