NL-OMON37049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. - 1160.89
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11(—)
入选标准
- •Stable pediatric patients objectively diagnosed with a venous thrombotic event
排除标准
- •- weight less than 9 kg;
- •- previous history of cerebral venous thromboembolism;
- •- conditions associated with a increased risk of bleeding;
- •- severe renal dysfunction;
- •- active infective endocarditis;
- •- hepatic disease.
研究者
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