NCT00234871已完成4 期
A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 357
- 主要终点
- Changes in urinary albumin:creatinine ratio
研究概览
简要总结
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension
- •Albuminuria
排除标准
- •Type 1 DM.
- •Subject has severe hepatic dysfunction at Screening as determined by liver function tests:
- •Bilirubin > 2.0 mg/dL.
- •ALT and/or AST > 3 times the upper limit of normal.
- •Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening.
- •Subject has non-diabetic renal disease.
- •Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.
研究组 & 干预措施
1
Active Comparator
干预措施: trandolapril/verapamil (Drug)
2
Active Comparator
干预措施: Lotrel (amlodipine/benazepril) (Drug)
结局指标
主要结局
Changes in urinary albumin:creatinine ratio
时间窗: 36 weeks
次要结局
- Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.(36 weeks)
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