跳至主要内容
临床试验/EUCTR2007-000501-29-DE
EUCTR2007-000501-29-DE进行中(未招募)不适用

ow grade albuminuria: reaching a new target for irbesartan

niversity Hospital of Erlangen0 个研究点目标入组 40 人开始时间: 2008年5月30日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40

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

  • Albumin excretion > 3,9 mg/g creatinine in men and > 7,5 mg/g creatinine in women confirmed on two occasions.
  • Age >=18 and <=75 years
  • 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

  • Antihypertensive treatment or blood pressure >= 140/90 mmHg
  • Antidiabetic treatment or blood glucose = 126 mg/dl
  • Blood pressure <120/80 mmHg
  • Treatment with lipid lowering drugs
  • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  • Treatment with any investigational product in the last 3 months before study entry
  • Breast-feeding
  • Childbearing potential (i.e. ovulating, pre-menopausal, not surgically sterile)
  • History of hypersensitivity to the investigational products or to drugs with similar chemical structures
  • Treatment with other ARBs in the last 4 weeks before study entry
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • History of drug or alcohol abuse
  • Impaired hepatic function, as shown by transaminases higher than the double of the upper normal limit
  • Impaired renal function, as shown by estimated GFR (abbreviated MDRD formula) <60 ml/min
  • any renal disease

研究者

发起方
niversity Hospital of Erlangen

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