EUCTR2008-006866-27-Outside-EU/EEA进行中（未招募）不适用
Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years
Boehringer Ingelheim (Canada) Ltd./Ltée0 个研究点目标入组 8 人开始时间: 2012年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
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) Males or females 12 to <18 years of age
- •2) Objective diagnosis of primary VTE
- •3) Completion of planned treatment course with low molecular weight heparin (LMWH) or
- •oral anticoagulant (OAC) for primary VTE with INR and aPTT both within normal limits
- •4) Written informed consent provided by the patient’s parent (or legal guardian) and assent
- •provided by the patient at the time of ICF signature.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Weight less than 32 kg
- •2)Conditions associated with an increased risk of bleeding
- •3) Severe renal dysfunction
- •4) Active infective endocarditis
- •5) Hepatic disease
- •6) pregnant females or females not using medically accepted contraceptive method
- •7) Anaemia or thrombocytopenia
- •8) use of prohibited or restricted drug within previous week
- •9) received investigational drug within past 30 days
研究者
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