跳至主要内容
临床试验/NCT01632878
NCT01632878已完成不适用

Omacor Plus Standard Therapies In Post MI Subjects Evaluation: The OPTIMISE Study

Mylan Inc.1 个研究点 分布在 1 个国家目标入组 1,531 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mylan Inc.
入组人数
1,531
试验地点
1
主要终点
Number of Occurrences of Cardio-vascular Events

研究概览

简要总结

The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed Omacor as part of their standard secondary prevention treatment. The aim is to observe the Omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or interventions will be mandated. Only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Occurrences of Cardio-vascular Events

时间窗: 12 months

Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)

次要结局

未报告次要终点

研究者

发起方
Mylan Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验