PRAGMATIC (This is the True Official Title of the Protocol for This Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,663
- 主要终点
- Number of Participants Reaching the Targeted LDL-C Levels
研究概览
简要总结
The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.
详细描述
The type of patient sampling used was consecutive patient sampling
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •man or woman aged over 18;
- •patient suffering from primary hypercholesterolemia;
- •patient justifying treatment with INEGY® (2nd intention);
- •patient currently treated with INEGY® for at least 4 weeks;
- •patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;
- •patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.
排除标准
- •patient not previously treated with a statin;
- •patient previously treated with a combination of hypolipemics;
- •patient treated with INEGY® as first intention;
- •patient treated with INEGY® for less than 4 weeks;
- •patient already included in this study.
研究组 & 干预措施
Subjects treated with INEGY
Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY
干预措施: INEGY (Drug)
结局指标
主要结局
Number of Participants Reaching the Targeted LDL-C Levels
时间窗: 1 to 3 months after starting treatment
A subject was considered to have met targeted LDL-C levels (been controlled) if: * subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L, * subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L, * subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L, * subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L, * subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L.
次要结局
未报告次要终点