CTRI/2009/091/000633招募中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.Acronym OPAL-2 - OPAL-2
SponsorAstellas Pharma Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subject 18 years of age or older with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
- •2.Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit.
排除标准
- •1.Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA).
- •2.Subject has active bleeding or any condition associated with increased risk of bleeding.
- •3.Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis).
- •4.Subject has an indication for warfarin other than AF (including planned cardioversion).
- •5.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.
- •6.Subject has a diagnosis of left ventricular aneurysm or atrial myxoma.
- •7.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)
- •8.Subject has active infective endocarditis.
- •9.Subject is planned for invasive procedures with potential for bleeding.
- •10.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.
- •11.Subject has participated in any YM150 clinical trials.
研究者
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