Randomized, Double-blind, Placebo-controlled Dose Modification Study to Evaluate the Safety and Efficacy of Single Doses of Vanoxerine for Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Conversion to Sinus Rhythm
研究概览
简要总结
Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.
详细描述
Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •provide written informed consent,
- •male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
- •symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
- •AF/AFL documented by ECG at the start of study drug administration
排除标准
- •Systolic blood pressure <100 mmHg.
- •Average heart rate <50 bpm.
- •Average QTcF (Fridericia correction) >440 ms.
- •Average QRS interval >140 ms.
- •Paced atrial or ventricular rhythm on ECG.
- •Serum potassium <3.5 meq/L (may be corrected prior to randomization).
- •Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
- •received amiodarone (oral or IV) in prior 3 months.
- •Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
- •Aortic stenosis with aortic valve area equal to or less than 1.0 cm
- •Rheumatic mitral stenosis with valve area of <1.5 cm
- •Untreated hyperthyroidism.
- •Acute pericarditis.
- •AF/AFL as a result of surgery within the last 7 days
- •History of failed electrical cardioversion
- •History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
- •History or family history of long QT syndrome.
- •History of ventricular tachycardia requiring drug or device therapy.
- •History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
- •Ejection fraction (EF) of 35% or less.
研究组 & 干预措施
vanoxerine 200mg
vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
干预措施: Vanoxerine (Drug)
placebo
placebo to match vanoxerine oral capsule
干预措施: Placebo (Drug)
vanoxerine 300mg
vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
干预措施: Vanoxerine (Drug)
vanoxerine 400mg
vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
干预措施: Vanoxerine (Drug)
结局指标
主要结局
Conversion to Sinus Rhythm
时间窗: baseline through 24 hours
proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
次要结局
未报告次要终点