EUCTR2007-000860-25-DK进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality - ALTITUDE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8,600
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
- •-Type 2 diabetes and at least one of the following:
- •*Macroalbuminuria
- •*Microalbuminuria and a reduced kidney function
- •*Previous heart attack and a reduced kidney function
- •*Previous stroke and a reduced kidney function
- •*Heart Failure a reduced kidney function
- •*Coronary artery disease a reduced kidney function
- •- Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •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 3977
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4295
排除标准
- •- Type 1 diabetes mellitus
- •- Cardiovascular event or procedure = 3 months prior to Visit 1
- •- Unstable serum creatinine
- •- Hypertension: Mean sitting systolic blood pressure (msSBP) = 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) = 85 and < 110 mmHg unless treated with at least 3 antihypertensive medications
- •- Hypertension msSBP = 170 or msDBP = 110 mmHg
- •- Baseline Serum Potassium > 5.0 mmol/L
- •- Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
- •- Patients with NYHA class III or IV heart failure
- •- Known renal artery stenosis
- •- Previous randomization into the AVOID trial (CSPP100C2201)
- •- Specific to the safety follow-up period: Aliskiren or aliskiren-containing fixed combination products must not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) in patients with diabetes.
- •- Specific to the safety follow-up period: Participation in another clinical trial, whether or not on investigational drug
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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