Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,084
- 主要终点
- Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice
详细描述
This special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the participant's triglyceride level.
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
- •Patients with hyperlipidemia
排除标准
- •Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
- •Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters
研究组 & 干预措施
Omega-3 fatty acid ethyl esters 2 g
Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals
干预措施: Omega-3 fatty acid ethyl esters (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: Up to Month 12
次要结局
- Percent Change From Baseline in Lipid Parameters - Apo-CIII(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - Lipoprotein(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - Apo-B(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)(Baseline, up to 12 months (Final Assessment Point))
- Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)(Baseline, up to 12 months (Final Assessment Point))