EUCTR2006-005408-14-GB进行中（未招募）1 期
An extension to study VAL489K2303 to evaluate the long term safety, tolerability and efficacy of valsartan in children 6 to 17 years of age with hypertension, versus enalapril treatment for 14 weeks, or combined with enalapril versus enalapril monotherapy for 66 weeks in chronic kidney disease patients.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
入选标准
- •Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
- •Additional inclusion criteria:
- •- Successful completion of 12 weeks of double blind treatment in core protocol
- •CVAL489K2302
- •- Discontinueing prematurely from teh core CVAL489K2302 study due to
- •uncontrolled hypertension defined as; MSSBP>20%, but ><25% above the 95th
- •percentile for age, gender, and height after visit 5, qualifies a patient for entry into
- •this extension study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
- •Additional exclusion criteria:-
- •- Patients who experienced any adverse events considered serious and drug
- •related in protocol CVAL489K2302 are exluded.
- •- Patients who live far from site and have logistic difficulties getting repeat serum potassium test performed within one week of first elevated values (K+>5.3) will not be considered for enrollment in this study.
研究者
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