NCT00171041已完成3 期
A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 265
- 试验地点
- 3
- 主要终点
- Change from baseline in sitting systolic blood pressure after 2 weeks
研究概览
简要总结
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- •CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
排除标准
- •BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE
- •SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
- •Other protocol-defined inclusion/exclusion criteria will also apply.
结局指标
主要结局
Change from baseline in sitting systolic blood pressure after 2 weeks
次要结局
- Change in diastolic blood pressure after 2 weeks to 4 weeks
- Change from baseline diastolic blood pressure after 2 weeks
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline diastolic blood pressure after 4 weeks
- Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
研究者
研究点 (3)
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