NCT00565396Unknown不适用
Multi-Center,Double-Blind,Randomized,Controlled Clinical Trial of Fosinopril and/or Losartan in Patients With Chronic Kidney Disease Stage 3
Shanghai Municipal Health Bureau26 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- progress to End Stage Renal Disease
研究概览
简要总结
The purpose of this study is to determine whether fosinopril and losartan are effective in the treatment of patients with Chronic Kidney Disease(CKD) stage 3.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years old
- •Roll out secondary renal diseases
- •Do not use steroids and immunosuppresive drugs
- •ACEI/ARB treated patients should have 7-14 days wash out period，SiDBP< 110mmHg
- •Willing and able to comprehend and give written informed consent
- •Willing to follow-up regularly
排除标准
- •Use steroids and immunosuppresive drugs
- •Secondary renal diseases
- •Acute cardio-cerebral diseases within 6 months
- •Post renal transplantation
- •Pregnant/Nursing women
- •History of hypersensitivity to ACEI/ARB
- •Refuse to join clinical trial
研究组 & 干预措施
1
Active Comparator
Fosinopril 10mg/day(oral)
干预措施: Fosinopril and Losartan (Drug)
2
Active Comparator
Fosinopril 20mg/day(oral)
干预措施: Fosinopril and Losartan (Drug)
3
Active Comparator
Losartan 50mg/day(oral)
干预措施: Fosinopril and Losartan (Drug)
4
Active Comparator
Losartan 100mg/day(oral)
干预措施: Fosinopril and Losartan (Drug)
结局指标
主要结局
progress to End Stage Renal Disease
时间窗: within two years
double of serum creatinine
时间窗: within two years
all cause mortality
时间窗: within two years
次要结局
- decreased proteinuria(within two years)
研究者
研究点 (26)
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