NCT00171028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 Hypertension Patients 1 - 5 Years Of Age
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
- 90
- 试验地点
- 2
- 主要终点
- Change from baseline systolic blood pressure after 2 and 4 weeks
研究概览
简要总结
Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents 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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT
- •PARENTAL CONSENT MUST BE GRANTED
排除标准
- •BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT
- •SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS
- •Other protocol-defined exclusion criteria will apply.
结局指标
主要结局
Change from baseline systolic blood pressure after 2 and 4 weeks
次要结局
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline diastolic blood pressure after 2 weeks
- Change in 2 week diastolic blood pressure after 2 more weeks
- Change in baseline diastolic blood pressure after 4 weeks
- Adverse events, serious adverse events, and laboratory values during 4 weeks
研究者
研究点 (2)
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