NCT00235014已完成4 期
A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
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
- 1,204
- 主要终点
- Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.
研究概览
简要总结
The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Hypertension
排除标准
- •Albuminuria (Phase A)
- •Non-diabetic renal disease
- •Subject has a hypersensitivity to ACE inhibitor, CCB
研究组 & 干预措施
A-1, B-1
Active Comparator
A-1 pertains to Phase 1; B-1 pertains to Phase 2
干预措施: trandolapril (Drug)
A-2, B-2
Active Comparator
A2 pertains to Phase 1; B-2 pertains to Phase 2
干预措施: trandolapril/verapamil (Drug)
A-3
Placebo Comparator
干预措施: placebo (Drug)
A-4
Active Comparator
干预措施: verapamil (Drug)
结局指标
主要结局
Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.
时间窗: 3 years
次要结局
- Course of albumin excretion over time, GFR, blood pressure (BP), incidence of major CV events, overall and CV mortality, HbA1c, progression of retinal changes.(3 years)
研究者
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