NCT00041509已完成2 期
ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 343
- 主要终点
- VTE
研究概览
简要总结
The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- •Patients who have given written informed consent to participate in this study.
排除标准
- •Patients with a contraindication to contrast venography
- •Patients with an increased risk of bleeding.
- •Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
- •Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
研究组 & 干预措施
SB424323, 500 mg BID
Experimental
干预措施: SB-424323 (Drug)
SB424323, 125 mg BID
Experimental
干预措施: SB-424323 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
VTE
时间窗: 28 day treatment period
Incidence of VTE during the 28-day treatment period, including death due to VTE
次要结局
- types of VTE(28 day treatment period)
研究者
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