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临床试验/EUCTR2008-008287-28-DE
EUCTR2008-008287-28-DE进行中(未招募)不适用

Effect of direct renin-inhibition aliskiren on renal haemodynamic and metabolic parameters in patients with prediabetes - AMARYLIS

niversity Hospital Erlangen0 个研究点目标入组 20 人开始时间: 2010年4月13日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adults aged > 18 to < 70 years
  • Prediabetes (HbA1c 5.7-6.4 %) impaired fasting glucose (blood glucose 100 - 126 mg/dl) or impaired glucose tolerance (IGT) (Blood glucose > 140 mg/dl and < 200 mg/dl 2 h after an oral glucose administration of 75g)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Diabetes Mellitus Type 1/2
  • Micro-, or Macroalbuminuria
  • Renal insufficiency
  • Secondary forms of arterial hypertension
  • Ongoing therapy with ACE-Inhibitors, AT1 blocker, direct renin inhibitor
  • Antihypertensive therapy with more than 2 agents
  • Uncontrolled Blood pressure
  • Known intolerance of direct renin inhibitor
  • Medical history of cerebral stroke or myocardial infarction within the last 6 months, chronic heart failure NYHA III-IV
  • Severe gastrointestinal disease
  • Elevated liver parameters (SGOT, SGPT > more than doubled)
  • Tablet or alcohol abuse
  • Adipositas per magna (BMI > 35kg/m²)
  • Malignant disease
  • Insufficient Compliance

研究者

发起方
niversity Hospital Erlangen

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