NL-OMON30473已完成2 期
A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centered Safety, Tolerability and Efficacy Study of RSD1235-SR to Prevent Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion - Prevention of AF Recurrence Post-Conversion Study
Cardiome Pharma0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- •-Signed and dated written informed consent form;
- •-Be 18 to 85 years of age;
- •-Men and women must be using an effective method of birth control;
- •-Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
- •-Have adequate anticoagulant therapy;
- •-Be heamodynamically stable;
- •-Have a body weight between 45 and 113 kg.
排除标准
- •-Pregnant or breast-feeding women;
- •-Have known prolonged QT syndrome or QTcB-interval of >0,500 sec, familial long QT
- •syndrome, previous Torsades de Pointes, ventricular fibrillation or sustained ventriculard ventrikeltachycardia;
- •-Have a QRS >0,140 sec;
- •-Documented previous episodes of second or third-degree atrioventricular block;
- •-Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
- •-Have clinically significant aortic valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
- •-Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
- •-Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
- •-Have serious diseases that could interfere with the conduct or validity of the study or compromise subject safety;
- •-Have known concurrent temporary secondary causes of AF;
- •-Have specific (stated in the protocol) values of K+ en Mg2+;
- •-Have clinical evidence of digoxin toxicity;
- •-Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
- •-Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
- •-Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
- •-Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
研究者
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