NCT00573430已完成4 期
A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy
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
- AstraZeneca
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
研究概览
简要总结
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
- •proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)
排除标准
- •Current serum-creatinine > 265 mmol/L (>3 mg/dL).
- •Current serum-potassium > 5.5 mmol/L
- •Known hypersensitivity to angiotensin (AT)1-receptor blocker
研究组 & 干预措施
1
Experimental
Candesartan Cilexetil
干预措施: Candesartan Cilexetil (Drug)
2
Experimental
Candesartan Cilexetil
干预措施: Candesartan Cilexetil (Drug)
3
Experimental
Candesartan Cilexetil
干预措施: Candesartan Cilexetil 32mg (Drug)
结局指标
主要结局
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
时间窗: baseline to 28 weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
次要结局
- Change of Systolic and Diastolic Blood Pressure From Baseline(baseline to 28 weeks)
- Inflammatory Marker (Hs-C-peptide Reactive Protein)(baseline to 28 weeks)
- Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation(28 weeks)
- Treatment-emergent Adverse Events(Baseline to 28 weeks)
研究者
研究点 (1)
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