A randomized, double-blind, placebo-controlled, parallelgroup 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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,606
- 试验地点
- 20
- 主要终点
- •Cardiovascular (CV) death
研究概览
简要总结
The purpose of this study is to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.
AMENDMENT 4 RATIONALE (MARCH 2012) :
Protocol amendment 4 serves to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addresses the subsequent Health Authorities request to implement a 12 month safety follow-up period post study drug discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 0.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age greater than 35 years •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.
排除标准
- •â€¢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 anti-hypertensive 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) EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:.
- •Aliskiren or aliskiren containing fixed combination products must not be used Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
•Cardiovascular (CV) death
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
•Resuscitated sudden death
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
•Non-fatal myocardial infarction (MI)
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
•Non-fatal stroke
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
•Onset of end-stage renal disease (ESRD) defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
•Doubling of baseline serum creatinine concentration to above the upper limit of normal according to the central laboratory, sustained for at least one month
时间窗: Time Frame: Time from randomization to the first event, Designated as safety issue: No
次要结局
- •Time from randomization to the first event of the following composite CV endpoint: Cardiovascular (CV) death, Resuscitated sudden death, Non-fatal myocardial infarction (MI), Non-fatal stroke, Unplanned hospitalization for heart failure (HF)(•Onset of end-stage renal disease (ESRD) defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death)