NCT02184858已完成4 期
Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental consent must be granted
- •Patient age: 1y - 18 y
- •Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
- •No reversible cause found on diagnostic work-up for hypertension
- •Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension
排除标准
- •Pregnancy
- •Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
- •Following abnormal laboratory values: Hyperkaliemia (serum potassium > 5.3mmol/L); Anemia (hemoglobin < 8g/dL); AST or ALT > 3 times the upper limit of reference range; Total bilirubin > 3 times the upper limit of reference range
- •Abnormalities of the oral cavity that can influence intake of medication
- •Known sensitivity to ACE-inhibitors
- •Known lactose intolerance
- •History of angioedema
- •Unilateral or bilateral stenosis of the renal artery
- •Diagnosis of heart failure (NYHA Class II-IV)
- •History of coarctation of the aorta
- •Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
研究组 & 干预措施
lisinopril
Experimental
dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.
干预措施: lisinopril, ACE-inhibitor (Drug)
结局指标
主要结局
blood pressure
时间窗: 4 months
次要结局
- Serum concentrations will be assessed after every dose titration(trough and 4 hours post dosing)
- Adverse events with assessment of specific blood parameters(up to 4 months)
研究者
研究点 (1)
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