A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 主要终点
- Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36
研究概览
简要总结
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
详细描述
The study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. Participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension was designed to continue until the 100th participant completed 3 years of follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 1 to 17 years of age
- •Able to provide a first-morning urine sample each day during the study
- •Documented history of proteinuria associated with chronic kidney disease of any origin
- •Signed consent of parent and/or legal guardian
排除标准
- •Pregnant and/or nursing
- •Requires more than 2 medications to control high blood pressure
- •Has undergone major organ transplantation (e.g. heart, kidney, liver)
- •Known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
- •Known sensitivity to amlodipine or other calcium channel blocker
- •Requires cyclosporine to treat renal disease (kidney disease)
研究组 & 干预措施
Amlodipine Double-Blind Base Study (12-weeks)
Hypertensive participants were randomized to receive either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo) for 12 weeks.
干预措施: Placebo (Losartan) (Other)
Losartan Double-Blind Base Study (12-weeks)
Normotensive participants received losartan.
Hypertensive participants received either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo).
干预措施: Losartan Potassium (Drug)
Losartan Open-Label Extension Phase (Month 36)
Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).
干预措施: Losartan Potassium (Drug)
Enalapril Open-Label Extension Phase (Month 36)
Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).
干预措施: Enalapril Maleate (Drug)
结局指标
主要结局
Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36
时间窗: Baseline and Month 36
Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline\*, after approximately three years of treatment. \*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase.
Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12
时间窗: Baseline and Week 12
Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline\*, after approximately twelve weeks of treatment. Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period.
Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36
时间窗: Baseline and Month 36
The outcome measure of glomerular filtration rate was based on mL/min/1.73m\^2, as determined by the Schwartz formula: GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL) GFR values were compared to the baseline GFR measure. \[Note: For male participants, ages 13 to 17 years, 0.70 was used as the multiplier in place of 0.55\] Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase.
次要结局
- Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12(Baseline and Week 12)
- Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12(Baseline and Week 12)