NL-OMON46324已完成2 期
Follow-up Safety Trial in children with chronic heart failure therapy receiving Orodispersible Minitablets of Enalapril (WP10 Trial). - WP10 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
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
- •-Patients from the WP08 and WP09 trials who have been treated with enalapril Orodispersible Minitablets and are still under ODMT treatment.
- •-Patients from the WP08 and WP09 trials who have been treated for at least 3 days with enalapril Orodispersible Minitablets and are not anymore under ODMT treatment.
- •-Patient and/or parent(s)/legal representative provided written informed consent for participation in this long term follow-up study and assent is received from the patient according to national legislation and as far as achievable from the child.
排除标准
- •Patients who have been enrolled and treated in the WP08 or WP09 trials have fulfilled the respective in- and exclusion criteria of those protocols. As it is the aim of this Follow-up Study to observe the safety of all patients exposed to enalapril ODMT treatment, no additional exclusion criteria are defined in this protocol.
研究者
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