NCT00448214已完成2 期
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin
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
- 448
- 主要终点
- All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
研究概览
简要总结
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for the study if all of the following apply:
- •Subject has paroxysmal permanent or persistent NVAF
- •Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
- •Legal minimum age requirement (country-specific).
- •Written informed consent has been obtained.
排除标准
- •History of heart valve disorders
- •History of rheumatic fever.
- •History of stroke and/or systemic embolism (including TIA).
- •History of Acute Coronary Syndrome (ACS).
- •Indication for warfarin other than NVAF.
- •Known hemorrhagic disorder and/or coagulation disorder.
- •Active bleeding or any condition associated with increased risk of bleeding.
研究组 & 干预措施
1
Experimental
Low dose
干预措施: YM150 (Drug)
2
Experimental
Middle dose
干预措施: YM150 (Drug)
3
Experimental
High dose
干预措施: YM150 (Drug)
4
Active Comparator
干预措施: warfarin (Drug)
结局指标
主要结局
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
时间窗: 16 Weeks
次要结局
- Incidence of symptomatic stroke(16 Weeks)
- Incidence of transient ischemic attack (TIA)(16 Weeks)
- Incidence of systemic thromboembolic event(16 Weeks)
- Incidence of the bleeding rates(16 Weeks)
- Other safety assessments(16 Weeks)
- PK, PD variables(16 Weeks)
研究者
相似试验
已完成
2 期
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee ReplacementThromboembolismNCT00408239Astellas Pharma Inc367
进行中（未招募）
不适用
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 - 150-CL-008EUCTR2005-002457-41-ITASTELLAS PHARMA960
进行中（未招募）
不适用
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-EEAstellas Pharma Europe B.V.960
进行中（未招募）
不适用
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）
不适用
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