EUCTR2011-002285-21-BE进行中(未招募)1 期
Evaluation of the long term safety of the use of dabigatran etexilate inpatients with a bileaflet mechanical heart valve. - RE-ALIGN-EX
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 405 人开始时间: 2011年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 405
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. Completed study 1160.113 per protocol
- •2. Continuing need for anticoagulation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. uncontrolled hypertension
- •2. severe renal impairment
- •3. active liver disease
- •4. increased risk of bleeding
研究者
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