A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- urinary albumin excretion or proteinuria at week 48
研究概览
简要总结
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.
详细描述
a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy
- Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day)
- Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes nephropathy
- •Urinary albumin excretion 1-3g/24hours
- •Serum creatinine < 3mg/dl
排除标准
- •Type 1 diabetes mellitus
- •Renal diseases other than type 2 Diabetes nephropathy
- •Renal artery stenosis
- •Severe heart diseases
- •Tuberculosis
研究组 & 干预措施
1
Valsartan (160mg/day)is given in combination with Placebo
干预措施: Valsartan (Drug)
1
Valsartan (160mg/day)is given in combination with Placebo
干预措施: Placebo (Drug)
2
Valsartan (160mg/day) + Probucol (750mg/day)
干预措施: Valsartan (Drug)
2
Valsartan (160mg/day) + Probucol (750mg/day)
干预措施: Probucol (Drug)
结局指标
主要结局
urinary albumin excretion or proteinuria at week 48
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
Wei Shi
Director of renal division of Guangdong General Hospital
Guangdong Provincial People's Hospital