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临床试验/NCT01393860
NCT01393860已完成不适用

Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?

Novartis1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Novartis
入组人数
200
试验地点
1
主要终点
Measure: Change in blood pressure

研究概览

简要总结

The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • Patients ages 18 yeras and older
  • Hypertension Diagnosis
  • Currently on at least 1 hypertensive medication
  • At least 2 lab measure before and after aliskiren initiation

排除标准

  • Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
  • Pregnancy
  • Development of secondary renal disease unrelated to diabetes (such as nephritis)
  • Terminal illness
  • AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Measure: Change in blood pressure

时间窗: baseline and 1 year

次要结局

  • Measure: Change in urine microalbumin(baseline and 1 year)
  • Measure: Change in creatinine(baseline and 1 year)
  • Measure: Change in potassium levels(baseline and 1 year)

研究者

发起方
Novartis
申办方类型
Industry

研究点 (1)

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Real-world Aliskiren Use in Diabetic Patients | 临床试验