NCT00938730已完成2 期
A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With 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
- 1,280
- 主要终点
- Incidence of major and clinically relevant non-major bleeding events
研究概览
简要总结
The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.
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
- •Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
- •Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit
排除标准
- •Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
- •Subject has active bleeding or any condition associated with increased risk of bleeding
- •Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
- •Subject has an indication for warfarin other than AF (including planned cardioversion)
- •Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
- •Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
- •Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics [such as tissue Plasminogen Activator (tPA), streptokinase], antiplatelet agents [such as cilostazol, clopidogrel, ticlopidine, dipyridamole], anticoagulants [such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors] and chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs] or acetylsalicylic acid use of >100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
- •Subject has active infective endocarditis
- •Subject is planned for invasive procedures with potential for bleeding
- •Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
- •Subject has participated in any YM150 clinical trials
研究组 & 干预措施
1. YM150, Dose W, twice daily
Experimental
干预措施: YM150 (Drug)
2. YM150, Dose X, once daily
Experimental
干预措施: YM150 (Drug)
3. YM150, Dose X, twice daily
Experimental
干预措施: YM150 (Drug)
4. YM150, Dose Y once daily
Experimental
干预措施: YM150 (Drug)
5. YM150, Dose Y twice daily
Experimental
干预措施: YM150 (Drug)
6. YM150, Dose Z, once daily
Experimental
干预措施: YM150 (Drug)
7. Warfarin
Active Comparator
干预措施: Warfarin (Drug)
结局指标
主要结局
Incidence of major and clinically relevant non-major bleeding events
时间窗: Double-blind treatment period (variable, up to 16 months)
次要结局
- Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths(Double-blind treatment period (variable, up to 16 months))
- Incidence of bleeding events(Double-blind treatment period (variable, up to 16 months))
- Assessment of other safety variables(Double blind treatment period (variable, up to 16 months))
- Assessment of PK/PD variables(Double-blind treatment period (up to week 12))
- Patient Reported Outcomes(Double-blind treatment period (up to week 24))
研究者
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