NCT01038895Unknown4 期
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
研究概览
简要总结
The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:
- Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
- Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •blood pressure > 130/80 <180/105 mmHg at the end of the wash-out
- •type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
- •microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)
排除标准
- •Pregnancy, lactation or women of childbearing age
- •Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
- •History of hypertensive encephalopathy or cerebrovascular accident within 6 months
- •Secondary hypertension
- •Heart Failure
- •Myocardial infarction within 6 months
- •Angina pectoris, clinically significant valvular disease or arrhythmia
- •Alteration indices of liver function or renal
- •Known hypersensitivity to ACE inhibitors
- •All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study
研究组 & 干预措施
Ramipril
Active Comparator
10 mg/daily
干预措施: Ramipril (Drug)
Aliskiren
Experimental
300 mg/ daily
干预措施: Experimental (Drug)
结局指标
主要结局
Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
时间窗: 3 months
次要结局
- Average of 24 hours by ABPM, systolic and diastolic blood pressure(3 months)
- Average daytime, systolic and diastolic blood pressure(3 months)
- Average night, systolic and diastolic blood pressure(3 months)
研究者
研究点 (1)
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