CTRI/2009/091/000909已完成3 期
ong-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at one year of age. - CLARINET LT
SanofiSynthelabo India Limited0 个研究点目标入组 47 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
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
入选标准
- •Patients randomized in the CLARINET study who still are receiving the study drug and with the palliative systemic-to-pulmonary artery shunt still in place at 1 year of age, − for whom the investigator?s decision is to continue the study drug treatment based on his/her judgment of the expected benefit/risk of continuing treatment with study drug.
排除标准
- •Patients who have had primary efficacy endpoint ( Shunt thrombosis and early cardiac related procedure of thrombotic nature) during the Clarient study.
研究者
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