NCT00171353已完成4 期
A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients
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
- 109
- 试验地点
- 1
- 主要终点
- Change from baseline in urine albumin excretion after 24 weeks
研究概览
简要总结
One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arterial hypertension without previous regular treatment
- •Urinary albumin excretion rate above 30 mg / 24h
- •30-65 years old
排除标准
- •Reno-vascular arterial hypertension
- •Therapy resistant edema
- •Chronic heart failure, angina pectoris
- •Diabetes mellitus
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change from baseline in urine albumin excretion after 24 weeks
Change from baseline in an ultrasound measurement of blood flow after 24 weeks
次要结局
- Effect of blood pressure changes on urine albumin excretion rate and blood vessel function
研究者
研究点 (1)
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