NCT00242346已完成3 期
A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 270
- 试验地点
- 26
- 主要终点
- To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
研究概览
简要总结
The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
- •Minimum 6-month history of hypertension and primary glomerular disease
- •Hypertensive nephrosclerosis
- •Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1
排除标准
- •Persistent hypertension
- •New anti-hypertensive medications started within 6 weeks of Visit 1
- •Significant cardiac disease or Liver disease
- •Females of childbearing potential without reliable contraception
- •Pregnant women and women who are breast-feeding
结局指标
主要结局
To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
次要结局
- To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
- To determine the effects of high dose candesartan cilexetil on blood pressure
研究者
研究点 (26)
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