NCT00171561已完成4 期
A 24-week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria
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
- 144
- 试验地点
- 1
- 主要终点
- Blood measures of hypertension after 24 weeks
研究概览
简要总结
The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •elevated blood pressure and pulse pressure
- •albuminuria
排除标准
- •Severe hypertension
- •History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
- •Liver, kidney (not caused by diabetes), or pancreas disease
- •Type 1 diabetes or uncontrolled type 2 diabetes
- •Allergy to certain medications used to treat high blood pressure
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Blood measures of hypertension after 24 weeks
次要结局
- Blood measures of hypertension in arterial system after 24 weeks
- Change in protein excretion rate after 24 weeks
- Change in serum markers of endothelial function and oxidative stress after 24 weeks
研究者
研究点 (1)
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