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临床试验/NCT01390415
NCT01390415已完成不适用

A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life

Organon and Co0 个研究点目标入组 136 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
主要终点
Number of Participants With Macroalbuminuria After 6 Months of Treatment

研究概览

简要总结

This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • Diabetes mellitus
  • Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
  • Microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
  • Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
  • Urinalysis with white blood cells (WBC) <5 cells per high power field
  • Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
  • Medical history and co-morbidities (if available) listed in medical records
  • Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available
  • Exclusion criteria:
  • Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
  • Enrollment in another clinical trial

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Macroalbuminuria After 6 Months of Treatment

时间窗: Baseline and Month 6

Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) \>300 mg/g and ≥30% increase from baseline.

次要结局

  • Systolic Blood Pressure (SBP)(Baseline and Month 6)
  • Diastolic Blood Pressure (DBP)(Baseline and Month 6)

研究者

申办方类型
Industry
责任方
Sponsor

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