Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 453
- 主要终点
- Number of Participants Reporting Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.
详细描述
Sampling method: invitation to the physician's patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice
排除标准
- 未提供
研究组 & 干预措施
Not previously treated
subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
干预措施: ezetimibe (Drug)
Not previously treated
subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
干预措施: statin (Drug)
Previously treated with statin
subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
干预措施: ezetimibe (Drug)
Previously treated with statin
subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
干预措施: statin (Drug)
结局指标
主要结局
Number of Participants Reporting Adverse Events
时间窗: 4-6 weeks after the first visit
Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)
Intensity of Adverse Events Reported
时间窗: 4-6 weeks after the first visit
Intensity of adverse events reported after co-administration therapy
Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy
时间窗: 4-6 weeks after the first visit
Achievement of LDL-C target levels as determined by physician
次要结局
未报告次要终点