NCT00751738已完成3 期
A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator
Forest Laboratories2 个研究点 分布在 2 个国家目标入组 330 人开始时间: 2002年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- safety of azimilide in this patient population
研究概览
简要总结
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
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
- 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
- •patients who completed at least 12 months on study 2000098 before inclusion in this study
排除标准
- •breast feeding or plan to become pregnant
- •used ticlopidine
- •were taking Class I or other Class III drugs
研究组 & 干预措施
1
Experimental
125 mg azimilide
干预措施: azimilide dihydrochloride (Drug)
结局指标
主要结局
safety of azimilide in this patient population
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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