EUCTR2006-004761-34-CZ进行中（未招募）不适用
A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacodynamics of YM150 in Subjects with Non-Valvular Atrial Fibrillation.
Astellas US Pharma US Inc.(APUS)0 个研究点目标入组 420 人开始时间: 2007年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Male or female subject is greater than or equal to 18 years of age.
- •3. Female subject of childbearing potential has a negative pregnancy test within 14 days prior to baseline/first dose of study drug OR is 2 years postmenopausal or surgically sterile.
- •4. Subject has permanent (documented by two ECGs within 3 months of randomization) or paroxysmal Non Atrial Valvular Fibrillation (NVAF) (documented on a 24 hour Holter monitor performed within 3 months of randomization).
- •5. Subject has prothrombin time international normalized ratio (INR) of 2.0 or below and an aPTT < 1.5 times the upper limit of normal.
- •6. Subject has CHADS2 stroke risk stratification score of 2 to 6.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female subject is pregnant or lactating.
- •2. Subject has current or recent (within previous 2 years) history of stroke and/or systemic embolism (including TIA).
- •3. Subject has active bleeding or any condition associated with increased risk of bleeding.
- •4. Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis).
- •5. Subject has an indication for warfarin other than AF (including mechanical heart valves, venous thromboembolism and planned cardioversion).
- •6. Subject has had myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months or diagnosis of Acute Coronary Syndrome (ACS).
- •7. Subject has a diagnosis of left ventricular aneurysm or atrial myxoma.
- •8. Subject requires use of prohibited concomitant medication (i.e. chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), thrombolytics or aspirin use of >100 mg/day) currently and for the duration of the study.
- •9. Subject has hematuria.
- •10. Subject has renal impairment (calculated creatinine clearance <30 ml/min).
- •11. Subject has hepatic insufficiency or presents with AST or ALT > 2 times the upper limit of normal.
- •12. Subject has bacterial endocarditis.
- •13. Subject has uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure > 110 mmHg).
- •14. Subject has history of rheumatic fever.
- •15. Subject has hemoglobin <10 g/dl or platelet count <100,000/µL.
- •16. Subject has any contraindications to warfarin.
- •17. Subject is a candidate for invasive procedures with potential for uncontrolled bleeding, including major surgery.
- •18. Subject has any concurrent illness which, in the opinion of the Investigator, may interfere with treatment or evaluation of safety or completion of this study.
- •19. Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days of screening for entry into the present study.
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