NCT00914524已完成2 期
An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- The change in the urinary protein/creatinine ratio from baseline to the end of treatment.
研究概览
简要总结
The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
- •normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg
排除标准
- •treatment with corticosteroids or immunosuppressants
- •treatment with antihypertensives (other than ARBs and ACE inhibitors)
- •serum potassium level of 5.5 mEq/l or above
- •serum creatinine level of 2.0 mg/dl or above
研究组 & 干预措施
Treatment
Experimental
16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12.
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
The change in the urinary protein/creatinine ratio from baseline to the end of treatment.
时间窗: baseline to 16 weeks
次要结局
- The change of creatinine clearance(baseline to 16 weeks)
研究者
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