NCT00446511已完成3 期
An Extension to Study Protocol CVAL489K2302 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 for 66 Weeks in Chronic Kidney Disease Patients.
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
- 250
- 试验地点
- 9
- 主要终点
- Number of Patients With Adverse Events
研究概览
简要总结
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
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
- •Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K
- •Patients participating in study CVAL489K2302 who may have discontinued prematurely 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.
排除标准
- •Renal artery stenosis.
- •Current diagnosis of heart failure (NYHA Class II-IV).
- •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 and AV block controlled with a pacemaker.
- •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.
- •Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
CKD patients: Valsartan+enalapril
Experimental
干预措施: Valsartan (Drug)
CKD patients: Valsartan+enalapril
Experimental
干预措施: Enalapril (Drug)
CKD patients: Enalapril
Active Comparator
干预措施: Enalapril (Drug)
CKD patients: Enalapril
Active Comparator
干预措施: placebo matched to valsartan (Drug)
Non-CKD patients: Valsartan
Experimental
干预措施: Valsartan (Drug)
Non-CKD patients: Valsartan
Experimental
干预措施: placebo matched to enalapril (Drug)
Non-CKD patients: Enalapril
Active Comparator
干预措施: Enalapril (Drug)
Non-CKD patients: Enalapril
Active Comparator
干预措施: placebo matched to valsartan (Drug)
结局指标
主要结局
Number of Patients With Adverse Events
时间窗: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26(Core Baseline (Week 0) to Week 26)
- Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26(Week 26)
- Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20(Core Baseline (Week 0) to Week 20)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26(Core Baseline (Week 0) to Week 26)
研究者
研究点 (9)
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