NCT00353678已完成2 期
Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,141
- 试验地点
- 79
- 主要终点
- Rate of total venous thromboembolism (VTE) during hospitalization phase
研究概览
简要总结
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective primary hip replacement
- •Age 18 years or over
- •Written informed consent obtained
排除标准
- •Documented history or considered at increased risk of venous thromboembolism
- •Subjects considered at increased risk of bleeding
- •Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- •Concomitant use of anticoagulants/ antiplatelet agents
结局指标
主要结局
Rate of total venous thromboembolism (VTE) during hospitalization phase
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
次要结局
- Rate of total VTE
- Incidence of the bleeding types:
- Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
- Symptomatic VTE
- Death due to any cause during treatment
- Major or clinically relevant non-major bleeding, Major bleeding,
- Clinically relevant non-major bleeding, Minor bleeding
研究者
研究点 (79)
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-PTAstellas Pharma Europe B.V.960
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2EUCTR2005-002457-41-NOAstellas Pharma Europe B.V.960
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-SEAstellas Pharma Europe B.V.960
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-FIAstellas Pharma Europe B.V.960
进行中（未招募）
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-DEAstellas Pharma Europe B.V.960