NCT00136773已完成4 期
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 332
- 主要终点
- Change from baseline in the urine albumin/creatinine ratio after 52 weeks
研究概览
简要总结
Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
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
- Double
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate hypertension
- •Type 2 diabetes mellitus
- •Presence of protein in the urine (albuminuria)
排除标准
- •Kidney disease not caused by diabetes or hypertension
- •Renal artery stenosis
- •Myocardial infarction or stroke within the last 6 months
- •Type 1 diabetes mellitus
- •Pregnant or lactating females
- •Cancer within the last 5 years
结局指标
主要结局
Change from baseline in the urine albumin/creatinine ratio after 52 weeks
次要结局
- Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
- Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
- Change from baseline in insulin resistance after 52 weeks
- Change from baseline in urine albumin secretion after 52 weeks
- Change from baseline in a marker of heart failure after 52 weeks
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