Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.

GlaxoSmithKline10 个研究点分布在 1 个国家开始时间: 2007年2月最近更新: 2013年4月4日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: GlaxoSmithKline
试验地点: 10
主要终点: Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.

时间窗: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.

次要结局

Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.(Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

研究点 (10)

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