NCT00408239已完成2 期
Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study
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
- 367
- 主要终点
- All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
研究概览
简要总结
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee 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
- None
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 total knee replacement surgery
- •Legal minimum age requirement ( country-specific)
- •Written informed consent has been obtained
排除标准
- •Documented history or considered to be at increased risk of venous thromboembolism
- •Subjects considered to be at increased risk of bleeding:
- •Known hemorrhagic disorder and/or coagulation disorder
- •Thrombocytopenia
- •Clinically important bleeding occurred within 3 months prior to the screening visit
- •Acute bacterial endocarditis
- •Severe hypertension
- •Retinopathy
- •Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
研究组 & 干预措施
1
Experimental
Dose regimen 1
干预措施: YM150 (Drug)
2
Active Comparator
干预措施: enoxaparin (Drug)
3
Experimental
Dose regimen 2
干预措施: YM150 (Drug)
结局指标
主要结局
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
时间窗: 2 Weeks
次要结局
- Venous thromboembolism and/or bleeds(2 Weeks)
- Other safety assessments(2 Weeks)
- PK, PD variables(2 Weeks)
研究者
相似试验
已完成
2 期
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial FibrillationAtrial FibrillationNCT00448214Astellas Pharma Inc448
已完成
1 期
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly SubjectsHealthy Elderly SubjectPharmacokinetic of YM150NCT01514825Astellas Pharma Inc36
已完成
3 期
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower ExtremitiesVenous ThromboembolismNCT00937911Astellas Pharma Inc101
已完成
3 期
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical IllnessVenous ThromboembolismNCT01028950Astellas Pharma Inc52
已完成
2 期
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)ThromboembolismNCT00353678Astellas Pharma Inc1,141