EUCTR2015-002397-21-GB进行中（未招募）不适用
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL - ENALONG
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •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 with at least 3 doses of enalapril Orodispersible Minitablets and are not anymore under ODMT treatment.
- •Patient and/or parent(s)/legal guardian provided written informed consent for participation in this long term follow-up study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •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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