Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,215
- 主要终点
- Rate of Cardiovascular (CV) Events
研究概览
简要总结
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
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 —（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
Rate of Cardiovascular (CV) Events
时间窗: up to 48 months
Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.
次要结局
- Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months(Baseline and Month 12)
- Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months(up to 48 months)
- Percentage of Participants With at Least 1 Discontinuation of Study Drug(up to 48 months)
- Percentage of Participants With CV Risk Factors(At enrollment (baseline))
- Mortality Rate(up to 48 months)