跳至主要内容
临床试验/NCT00389792
NCT00389792已完成2 期

A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities

ARYx Therapeutics2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
72
试验地点
2
主要终点
Efficacy Measure: Atrial Fibrillation Burden

研究概览

简要总结

The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.

详细描述

ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.

This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)

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
Triple (Participant, Care Provider, 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

入选标准

  • Proven paroxysmal atrial fibrillation
  • Pacemaker with appropriate AF diagnostics and recording capabilities

排除标准

  • Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity
  • Cardioversion within one month of screening
  • Severe left ventricular dysfunction or CHF with NYHA Class III or above

研究组 & 干预措施

ATI-2042 400 mg

No Intervention

干预措施: ATI-2042 (Drug)

ATI-2042 200 mg

No Intervention

干预措施: ATI-2042 (Drug)

ATI-2042 200 mg

No Intervention

干预措施: ATI-2042 200 mg (Drug)

ATI-2042 400 mg

No Intervention

干预措施: ATI-2042 200 mg (Drug)

ATI-2042 600 mg

No Intervention

干预措施: ATI-2042 (Drug)

ATI-2042 600 mg

No Intervention

干预措施: ATI-2042 200 mg (Drug)

ATI-2042 Placebo

No Intervention

干预措施: ATI-2042 (Drug)

ATI-2042 Placebo

No Intervention

干预措施: ATI-2042 200 mg (Drug)

结局指标

主要结局

Efficacy Measure: Atrial Fibrillation Burden

Safety Measures: ECG, Laboratory and Adverse Events

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (2)

Loading locations...

相似试验

Efficacy and Safety Study of an Antiarrhythmic Drug... | 临床试验