EUCTR2004-001766-40-DK进行中（未招募）不适用
Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter. - MAIA
Sanofi-Synthelabo Recherche0 个研究点目标入组 660 人开始时间: 2004年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with documented sinus rhythm for at least 1 hour at the time of randomization (two 12-lead ECGs at least 1 hour apart and both showing sinus rhythm on the day of randomization must be available);
- •With at least one 12-lead ECG documented AF/AFL apisode in the last 3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients of either sex aged below 21 years;
- •Women of chibearing potential without adequate birthcontrol;
- •Pregnant women; Breastfeeding women.
- •Unstable angina pectoris;
- •Documented AF/AFL episode motivating inclusion in the study starting and not persisting beyond 10 days after an acute condition known to cause AF/AFL;
- •History of torsade de pointe;
- •Congenital long QT syndrome;
- •QT syndrome up to 500 msec;
- •Family history of sudden cardiac death below age 50 years in the absence of coronary heart disease;
- •Wolff-Parkinson-White syndrome;
- •History of high degree atrio-ventricular block or significant sinus node disease without a permanent pacemaker implanted.
- •Patients in whom amiodarone prescribed for sinus rhythm maintenance was dicontinued for inefficacy;
- •Patients in whom 3 or more class 1 or 3 antiarrhythmic drugs prescribed for sinus rhythm maintenance were discontinuated for inefficacy.
- •Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease.
- •patients for whom the washout requirements for previous amiodarone treatment cannot be respected;
- •Patients in whom a contra-indicated concomitant treatment is mandatory (drug which can cause torsade de pointe);
- •Treatment with other class 1 or 3 antiarrhythmic drugs which cannot be discontinuated with the required washout period before the first study drug administration.
- •Hyperthyroïdism;
- •Hypothyroïdism;
- •Other contra-indications to amiodarone.
研究者
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