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
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