Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 14
- 主要终点
- Identify the genetic factors
研究概览
简要总结
More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.
Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.
The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.
Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identify the genetic factors
时间窗: 12 months
Identify the genetic factors involved in the individual susceptibility to develop a valvulopathy during a medicinal exposure in the benfluorex.
次要结局
- Compare the quality of life(12 months)