An Efficacy and Safety Study of HCP1105 Capsule in Combined Hyperlipidemic Patients With High Risk for Coronary Heart Disease (CHD): A Randomized,Double-blind, Multicenter, Phase 3 Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Mean rate of change of non-HDL-C (%) from baseline
研究概览
简要总结
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.
详细描述
An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3
- •Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)
研究组 & 干预措施
experimental sequence
Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
干预措施: HCP1105 (Drug)
experimental sequence
Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
干预措施: HGP0816 (Drug)
experimental sequence
Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
干预措施: Placebo of HGP0816 (Drug)
comparative sequence
Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg
干预措施: HGP0816 (Drug)
comparative sequence
Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg
干预措施: Placebo of HCP1105 (Drug)
结局指标
主要结局
Mean rate of change of non-HDL-C (%) from baseline
时间窗: 12 weeks
次要结局
- Mean rate of change of Total apo A1 (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of Triglyceride (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of Total cholesterol (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of HDL-C (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of LDL-C (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of Total apo B (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of Lipoprotein(a) (%) from baseline(4, 8, 12 weeks)
- Mean rate of change of hs-CRP (%) from baseline(4, 8, 12 weeks)
- Rate of the subjects who meet the target level of treatment(4, 8, 12 weeks)