A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- % Change of LDL-C
研究概览
简要总结
A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Both gender, the person aged 19 or older
- •Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia
- •LDL- C ≤ 250 mg/dL and TG < 500 mg/dL on fasting status
排除标准
- •Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1
- •Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 on Visit 1
- •Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1
研究组 & 干预措施
DW1125
1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
干预措施: Ezetimibe/Atorvastatin 10/5 mg (Drug)
DW1125
1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
干预措施: DW1125A placebo (Drug)
DW1125
1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
干预措施: DW1125E placebo (Drug)
DW1125
1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
干预措施: DW1125A-1 placebo (Drug)
DW1125A
1 Atorvastatin 5 mg tablet orally once daily
干预措施: Atorvastatin 5mg (Drug)
DW1125A
1 Atorvastatin 5 mg tablet orally once daily
干预措施: DW1125 placebo (Drug)
DW1125A
1 Atorvastatin 5 mg tablet orally once daily
干预措施: DW1125E placebo (Drug)
DW1125A
1 Atorvastatin 5 mg tablet orally once daily
干预措施: DW1125A-1 placebo (Drug)
DW1125E
1 Ezetimibe 10mg tablet orally once daily
干预措施: Ezetimibe 10mg (Drug)
DW1125E
1 Ezetimibe 10mg tablet orally once daily
干预措施: DW1125 placebo (Drug)
DW1125E
1 Ezetimibe 10mg tablet orally once daily
干预措施: DW1125A placebo (Drug)
DW1125A-1
1 Atorvastatin 10mg tablet orally once daily
干预措施: DW1125E placebo (Drug)
DW1125E
1 Ezetimibe 10mg tablet orally once daily
干预措施: DW1125A-1 placebo (Drug)
DW1125A-1
1 Atorvastatin 10mg tablet orally once daily
干预措施: Atorvastatin 10mg (Drug)
DW1125A-1
1 Atorvastatin 10mg tablet orally once daily
干预措施: DW1125 placebo (Drug)
DW1125A-1
1 Atorvastatin 10mg tablet orally once daily
干预措施: DW1125A placebo (Drug)
结局指标
主要结局
% Change of LDL-C
时间窗: 8 weeks
% Change of LDL-C in week 8 from baseline
次要结局
- % Change of LDL-C(4 weeks)
- % Change of Lipid parameters(4 weeks and 8 weeks)
- LDL-C goal achievement rates(4 weeks and 8 weeks)