EUCTR2006-005951-14-SI进行中（未招募）1 期
A prospective, randomised, open-label blinded end point (PROBE) trial to evaluate, whether, at comparable blood pressure control, combined therapy with the ACE inhibitor benazepril and the angiotensin II receptor blocker (ARB) valsartan reduces progression to ESRD more effectively than benazepril or valsartan alone in high risk patients with type 2 diabetes and overt nephropathy (VALID study) - VALID study
Italian Drug Agency0 个研究点目标入组 103 人开始时间: 2010年12月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 103
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
- Female
入选标准
- •- Males and females >40 years old;
- •- High-risk subjects with type 2 diabetes (WHO criteria);
- •- Serum creatinine concentration of 1.8 mg/dl or more (but less than 3.5 mg/dl);
- •- Urinary albumin to creatinine ratio of 2000mg/g or more (in spot morning urine);
- •- Legal capacity;
- •- Written informed consent.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Specific contraindications or history of hypersensitivity to the study drugs or
- •- Serum potassium = 6 mEq/L despite diuretic therapy, and optimized metabolic
- •and acid/base control;
- •- Bilateral renal artery stenosis;
- •- Previous history of allergy or intolerance, or evidence of immunologicallymediated
- •renal disease, systemic diseases, cancer;
- •- Drug or alcohol abuse;
- •- Any chronic clinical conditions that may affect completion of the trial or confound
- •data interpretation;
- •- Pregnancy or lactating;
- •- Women of childbearing potential without following a scientifically accepted form
- •of contraception;
- •- Legal incapacity and/or other circumstances rendering the patient unable to
- •understand the nature, scope and possible consequence of the trial;
- •- Evidence of an uncooperative attitude;
- •- Any evidence that patient will not be able to complete the trial follow-up.
研究者
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