NCT00435162已完成3 期
A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.
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
- 74
- 试验地点
- 11
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).
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 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
- •Must be able to swallow liquid formulation
- •Must be ≥ 6 kg or ≤ 40 kg at randomization
- •Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
- •If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
- •If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
- •Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
排除标准
- •Patients with background ARB therapy
- •Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
- •AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
- •Glomerular filtration rate < 30 mL/min/1.73m²
- •Serum potassium > upper limit of the reference range
- •MSSBP ≥ 25% above the 95th percentile
- •Patients exhibiting clinically significant ECG abnormalities
- •Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Low Dose
Experimental
干预措施: Valsartan 0.25 mg/kg (Drug)
Medium Dose
Experimental
干预措施: Valsartan 1.0 mg/kg (Drug)
High Dose
Experimental
干预措施: Valsartan 4.0 mg/kg (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
时间窗: baseline and week 6
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)(baseline and week 6)
- Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)(week 6 and week 8)
- Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)(week 6 and week 8)
研究者
研究点 (11)
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