NCT00433836已完成3 期
A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ages 6-17, with a documented history of hypertension
- •Must be able to swallow a pill
- •Must be ≥ 18 kg or ≤160 kg
- •MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement
- •Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)
排除标准
- •Renal artery stenosis
- •Current diagnosis of heart failure (NYHA Class II-IV).
- •MSSBP ≥ 25% above the 95th percentile
- •Second or third degree heart block without a pacemaker.
- •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •Clinically significant valvular heart disease.
- •Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy.
- •Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Valsartan 80 mg
Experimental
干预措施: Valsartan (Drug)
Valsartan 160 mg
Experimental
干预措施: Valsartan (Drug)
Valsartan 320 mg
Experimental
干预措施: Valsartan (Drug)
Enalapril 10 mg
Active Comparator
干预措施: Enalapril (Drug)
Enalapril 20 mg
Active Comparator
干预措施: Enalapril (Drug)
Enalapril 40 mg
Active Comparator
干预措施: Enalapril (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: Baseline and Week 12
Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline and Week 12)
- Decrease in MSSBP to < 95th Percentile for Age, Gender and Height(at week 12)
- Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients(Baseline and Week 8)
研究者
研究点 (11)
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