EUCTR2006-005954-62-IT进行中（未招募）1 期
A prospective, randomized, 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 the incidence of microalbuminuria more effectively than Benazepril or Valsartan alone in hypertensive patients with type 2 diabetes and high-normal albuminuria VARIETY Study - VARIETY Study
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 1,233 人开始时间: 2007年3月29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
- 1,233
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
- •-Males and females 40 years old; -High-risk subjects with type 2 diabetes WHO criteria ; -History of diabetes not exceeding 25 years; -High blood pressure systolic and/or diastolic blood pressure 135/85 mmHg or concomitant treatment with blood pressure lowering medications ; -Serum creatinine concentration 1.5 mg/dl; -Overnight urinary albumin excretion in at least 2 of 3 consecutive overnight urine collections 10 and 20 g/min; -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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Uncontrolled diabetes glycated hemoglobin 11 ; -Specific contraindications or history of hypersensitivity to the study drugs; -Serum potassium 8805; 5.5 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 immunologically-mediated 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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