A Methodological Open-Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarisation and QT Interval At Fixed Heart Rate Under Autonomic Blockade

Pfizer6 个研究点分布在 2 个国家目标入组 36 人开始时间: 2005年3月最近更新: 2006年11月8日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 36
试验地点: 6
主要终点: QT and QTc changes at two different pacing rates in atrially paced patients

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin effect on QT and QTc will also be assessed in atrially paced patients at two different pacing rates with and without autonomic blockade

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Ect
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with pace-makers but otherwise normal ventricular function

排除标准

•Nitrates, beta blockers

结局指标

主要结局

QT and QTc changes at two different pacing rates in atrially paced patients

次要结局

Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (6)

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