NCT00171119终止4 期
A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change from baseline in urine albumin excretion rate after 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.
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
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
- •patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
- •patients who give written, signed, informed consent.
- •patients with/without mild /moderate hypertension.
- •patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
- •patients without any accompanying systemic disease
排除标准
- •pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
- •patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in urine albumin excretion rate after 24 weeks
次要结局
- Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry
- Percent of patients returning to normal urine albumin excretion rate after 24 weeks
研究者
研究点 (1)
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