CTRI/2009/091/000197已完成3 期
A 36-week, multicenter, randomized, double-blind, placebocontrolled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricularremodeling in high risk post-acute myocardial infarctionpatients when added to optimized standard therapy
ovartis Healthcare Pvt Ltd0 个研究点目标入组 800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male or female patients 18 years and older.
- •2) Patients within 7-42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction.
- •3) Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial.
- •4) Patients must be on stable doses of the following concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:
- •oA Beta-blocker
- •oAn Anti-platelet agent
- •oAn evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both.
- •5) Qualifying Echocardiogram at Visit 1
排除标准
- •1) Patients requiring both Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin Receptor Blocker (ARB) combination therapy at V1 or any time during the study.
- •2) Severe refractory hypertension defined as MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg) at Visit 2.
- •3) Cardiogenic shock or systolic BP < 100 mmHg or diastolic < 60 mmHg within the 24 hours prior to Visits 1 or 2
- •4) Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD formula at Visit 1.
- •5) Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1
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