NCT01053910已完成4 期
A Multicentre Open, Non Comparative Study of the Safety of Ramipril (Tritace) 10 mg/Day in Prevention of Cardiovascular Events in High-risk Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,012
- 试验地点
- 1
- 主要终点
- Number of patient reaching the 10mg/day dose level
研究概览
简要总结
The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of coronary artery disease,
- •Stable heart failure
- •Peripheral vascular disease, or diabetes with at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, cigarette smoking, or documented microalbuminuria).
排除标准
- •Non stabilized or NYHA grade IV heart failure patients
- •Hemodynamically significant primary valvular or outflow tract obstruction (eg. mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)
- •Constrictive pericarditis.
- •Complex congenital heart disease.
- •Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic cardiac arrhythmias including ventricular tachycardia are not an exclusion criterion).
- •Planned cardiac surgery or angioplasty within 3 months (patient may be reconsidered for the trial after the procedure).
- •Cor pulmonale.
- •Heart transplant recipient.
- •Significant renal disease defined as:
- •Renal artery stenosis;
- •Creatine clearance <0.6 ml/second or serum creatinine≥ 200 mEq/L (≥2.26 mg/dl)
- •Overt nephropathy: ≥1 plus proteinuria on dipstick or urinary albumin excretion > 200 micrograms/minute (300 mg/24 hrs)
- •Hyperkalemia; K>5.5 mEq/L.
- •Patient is simultaneously taking another experimental drug.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Ramipril
Experimental
Duration of treatment: 2 months 7 first days: 1.25mg once daily in patients with stable heart failure and 7 days 2.5mg once daily or 14 first days:2.5mg once daily in patients without heart failure for 14 more days:5mg once daily maintenance therapy for 1 month: 10 mg (5mg, 2 tablets)
干预措施: Ramipril (Drug)
结局指标
主要结局
Number of patient reaching the 10mg/day dose level
时间窗: 30 days after the treatment start
Overall number of adverse events
时间窗: at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)
次要结局
未报告次要终点
研究者
研究点 (1)
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