NCT00696631终止3 期
Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 653
- 试验地点
- 1
- 主要终点
- Death from any cause or adjudicated hospitalization for worsening heart failure
研究概览
简要总结
The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV
- •Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%.
排除标准
- •acute pulmonary edema within 12 hours prior to start of study medication
- •various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia <50 bpm and/or PR-interval ≥280 ms, QTc-interval >500 ms, significant sinus node disease)
- •any illness or disorder other than CHF (cancer with metastasis, organ transplantation)
- •current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs
- •pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control
- •serum potassium <3.5 mmol/L.
- •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
Dronedarone 400mg bid
Experimental
dronedarone 400mg tablets
干预措施: Dronedarone (SR33589) (Drug)
Placebo
Placebo Comparator
matching placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Death from any cause or adjudicated hospitalization for worsening heart failure
时间窗: Until study cut-off date
次要结局
未报告次要终点
研究者
研究点 (1)
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