EUCTR2006-006415-74-Outside-EU/EEA进行中(未招募)不适用
A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension - Proteinuria in Pediatric Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is male or female from 1 to 17 years of age for the non-hypertensive strata or 6-17 years of age for the hypertensive strata; patient has a stable urine protein/creatinine ratio of >0.3 based upon the mean of three samples obtained during baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is pregnant or nursing; patient has severe hypertension or significant coronary, neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease, or known history of uncorrected coarctation of the aorta, bilateral renal artery stenosis, or renal artery stenosis to a single kidney; major organ transplantation; steroid-responsive nephrotic-range proteinuria; clinically important lab abnormalities; significant rhythm disturbance; ACEI or ARB within 28 days; sensitivity to ACEI, ARB, or calcium channel blocker, or history of angioedema; requirement for cyclosporine or tacrolimus to treat renal disease.
研究者
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