ACTRN12613000702718尚未招募4 期
A randomized, open label, two-way, two-period, crossover study comparing therapeutic effect of two warfarin brands in clinically stable patients already receiving warfarin treatment
Therapeutcs Research Centre, University of South Australia0 个研究点目标入组 50 人开始时间: 2013年6月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age greater than or equal to 18 years
- •2. Receiving warfarin treatment
- •3. Clinically stable with the same dose of warfarin yielding a stable (less than 0.5 unit change over the lead-in period) of INR value that falls within the target therapeutic range (2.0 -3.0 or 2.5-3.5) for at least 6 weeks
排除标准
- •1. Age less than 18 years
- •2. Allergy to any ingredients in warfarin product
- •3. Pregnancy or breast feeding
- •4. Non-adherence tendency
- •5. Psychiatric disorder or dementia
- •6. Significant renal dysfunction (adjusted creatinine clearance calculated by Cockcroft-Gault equation < 60 mL/min)
- •7. Significant liver dysfunction (AST, ALT > 3 times of upper limits)
- •8. Excessive alcohol consumption
- •9. Taking any medications, food or dietary supplement that significantly interact with warfarin
- •10. Limited English communication proficiency
研究者
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