A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Change form baseline in LDL-C
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
详细描述
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.
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
- •Adult, at least 19 years of age.
- •Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
- •Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
- •Drug compliance during Run-in period ≥70%
- •Patients must willing to the study and signed an informed consent
排除标准
- •Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
- •Patients with acute arterial disease
- •Patients with renal dysfunction or Serum creatinine level ≥2x ULN
- •Patients with liver dysfunction or ALT, AST level > 2xULN
- •Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
- •Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
- •Patients who have a history or presence of active malignancy within 5 years
- •Patients with difficulty of stop taking lipid-lowering agents during run-in period.
- •Patients who have taken another investigational drug within 4 weeks prior to screening visit.
研究组 & 干预措施
Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)
干预措施: Atorvastatin10mg, Ezetimibe10mg (Drug)
Atorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, placebo will be administered (Duration 8 weeks)
干预措施: Atorvastatin10mg, Ezetimibe placebo (Drug)
Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)
干预措施: Atorvastatin20mg, Ezetimibe10mg (Drug)
Atorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, placebo will be administered (Duration 8 weeks)
干预措施: Atorvastatin20mg, Ezetimibe placebo (Drug)
Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)
干预措施: Atorvastatin40mg, Ezetimibe10mg (Drug)
Atorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, placebo will be administered (Duration 8 weeks)
干预措施: Atorvastatin40mg, Ezetimibe placebo (Drug)
结局指标
主要结局
Change form baseline in LDL-C
时间窗: up to week 8
次要结局
- Change form baseline in Apo-B ratio(up to week 20)
- Change form baseline in LDL-C(up to week 20)
- Change form baseline in Total cholesterol(up to week 20)
- Change form baseline in Triglyceride(up to week 20)
- Change form baseline in HDL-C(up to week 20)
- Change form baseline in Apo-B(up to week 20)
- Change form baseline in Apo-A1(up to week 20)
- Change form baseline in Apo-B/Apo-A1 ratio(up to week 20)
- Change form baseline in Non-HDL-C(up to week 20)
- Change form baseline in LDL-C/HDL-C ratio(up to week 20)
- Change form baseline in TC/HDL-C ratio(up to week 20)
- Change form baseline in Non-HDL-C/HDL-C ratio(up to week 20)