NCT00334581已完成4 期
A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
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
- Sanofi
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The difference of urinary albumin excretion rate change
研究概览
简要总结
Primary objective:
- To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.
Secondary objectives:
- To determine how well irbesartan 300mg is tolerated versus 150mg
- To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
- •Blood pressure of < 180/110mmHg at baseline
- •Normal serum creatinine
排除标准
- •Type 1 diabetes
- •Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
- •Pregnant or lactating women
- •Severe hypertension
- •Overt nephropathy
- •Allergy to study drug
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Irbesartan 150mg
干预措施: Irbesartan (Drug)
2
Experimental
Irbesartan 300mg
干预措施: Irbesartan (Drug)
结局指标
主要结局
The difference of urinary albumin excretion rate change
时间窗: at week 24
次要结局
- Percentage of patients reaching target BP of 130/80mmHg(At week 24)
- Adverse events(From the beginning to the end of the study)
研究者
研究点 (1)
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