NL-OMON30339已完成3 期
A 36 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarct patients when added to optimized standard therapy - ASPIRE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •See protocol for complete criteria (page 17);*Male and female patients 18 years and older.
- •*Patients within 7-42 days of an acute myocardial infarction.
- •*Documented left ventricular systolic dysfunction associated with the qualifying acute myocardial infarction obtained as a clinical study at least 5 days after the qualifying MI but prior to Visit 1.
- •*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:
- •* A Beta-blocker
- •* An Anti-platelet agent
- •* A Statin
- •* An evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both.
排除标准
- •See protocol for complete criteria (page 18)
- •*Patients requiring both ACE and ARB combination therapy at Visit 1.
- •*Severe refractory hypertension defined as MSSBP *180 mmHg and/or MSDBP * 110 mmHg at randomization (visit 2).
- •*Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy
- •*Stroke or transchemient ischemic event (TIA) within 6 months of Study visit 1.
- •*Serum potassium *5.1 mEq/L, or dehydration at study visit 1
- •*Estimated Glomerular filtration rate < 30ml/min/1.73m2 using the MDRD formula at visit 1
- •*Unstable angina requiring intervention between visit 1 and visit 2.
- •*Any coronary artery revascularization procedure within 7 days prior to visit 1.
研究者
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