NCT01461499已完成4 期
Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Reduction in Albuminuria
研究概览
简要总结
The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Segment: outpatients
- •Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
- •Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
- •Microalbuminuria: 10 < and < 300 mg/gCr
- •Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent
排除标准
- •Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
- •Type 1 diabetes
- •Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
- •Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
- •Serum potassium > 5.6 mEq/L (hyperkalemia)
- •Urinary microalbumin < 10 or > 300 mg/gCr
- •Patients who participated in another clinical study within three months
研究组 & 干预措施
Direct renin inhibitor
Active Comparator
干预措施: Aliskiren (Drug)
Angiotensin receptor blockers
Active Comparator
干预措施: any angiotensin receptor blockers (Drug)
结局指标
主要结局
Reduction in Albuminuria
时间窗: baseline and 24 weeks
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
次要结局
- Change in the Urinary Angiotensinogen Level(baseline and 24 weeks)
- Change in the Plasma Renin Activity(baseline and 24 weeks)
- Change in the Serum Insulin Level(baseline and 24 weeks)
研究者
Hiroshi Maegawa
Professor of Medicine
Shiga University
研究点 (1)
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