NCT00752596已完成2 期
Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2005年9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
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- There was no outcome measure in this compassionate use
研究概览
简要总结
This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy
排除标准
- •Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
- •Is unwilling or unable to give or understand informed consent.
研究组 & 干预措施
1
Experimental
1 tablet of 125 mg/day of azimilide 2HCl, oral
干预措施: Azimilide 2HCl (Drug)
结局指标
主要结局
There was no outcome measure in this compassionate use
次要结局
未报告次要终点
研究者
研究点 (1)
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