NCT01773174撤回2 期
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Incidence of all bleeding events
研究概览
简要总结
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dabigatran etexilate
Experimental
single dose treatment with dabigatran oral solution
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
Incidence of all bleeding events
时间窗: 30 days
Plasma concentrations of total dabigatran
时间窗: one day
Plasma concentrations of BIBR 1048 BS (Base)
时间窗: one day
Incidence of all adverse events
时间窗: 30 days
Plasma concentrations of free dabigatran
时间窗: one day
Plasma concentrations of BIBR 1087 SE (Acid)
时间窗: one day
Ecarin clotting time (ECT)
时间窗: one day
Factor IIa inhibition
时间窗: one day
Plasma concentrations of BIBR 951 BS
时间窗: one day
Activated prothrombin time (aPTT)
时间窗: one day
次要结局
- Global assessment of tolerability will be summarized across all patients in the treated set(30 days)
- Changes in laboratory and clinical parameters(30 days)
- Patient assessment of taste will be summarized across all patients in the treated set(one day)
研究者
研究点 (8)
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相似试验
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Single dose safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of ageEUCTR2009-013618-29-BESCS Boehringer Ingelheim Comm.V16
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Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of ageEUCTR2009-013618-29-ATBoehringer Ingelheim RCV GmbH & Co KG16
撤回
2 期
Single dose open-label PK/PD, safety and tolerability of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years and 1 year to less than 2 years.bloodclotdeep venous thromboembolism10014523NL-OMON37049Boehringer Ingelheim3
进行中（未招募）
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Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of ageEUCTR2009-013618-29-LTBoehringer Ingelheim RCV GmbH & Co KG16
进行中（未招募）
1 期
Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of ageEUCTR2009-013618-29-Outside-EU/EEABoehringer Ingelheim (Canada) Ltd/Ltée16