A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Percent change from baseline to 8 weeks in LDL-Cholesterol
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
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
- Triple (Participant, 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
- •Aged over 19 years
- •Signed informed consent form
- •At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL
排除标准
- •Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
- •Liver transaminases > 2 x upper limit of normal
研究组 & 干预措施
Rosuvastatin 5mg & Placebo & Placebo
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
干预措施: Rosuvastatin 5mg (Drug)
Rosuvastatin 5mg & Placebo & Placebo
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) (Drug)
Rosuvastatin 5mg & Placebo & Placebo
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) (Drug)
DP-R207 5/10mg & Placebo & Placebo
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
干预措施: DP-R207 5/10mg (Drug)
DP-R207 5/10mg & Placebo & Placebo
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) (Drug)
DP-R207 5/10mg & Placebo & Placebo
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) (Drug)
Rosuvastatin 10mg & Placebo & Placebo
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
干预措施: Rosuvastatin 10mg (Drug)
Rosuvastatin 10mg & Placebo & Placebo
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) (Drug)
Rosuvastatin 10mg & Placebo & Placebo
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) (Drug)
DP-R207 10/10mg & Placebo & Placebo
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
干预措施: DP-R207 10/10mg (Drug)
DP-R207 10/10mg & Placebo & Placebo
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) (Drug)
DP-R207 10/10mg & Placebo & Placebo
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) (Drug)
Rosuvastatin 20mg & Placebo & Placebo
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
干预措施: Rosuvastatin 20mg (Drug)
Rosuvastatin 20mg & Placebo & Placebo
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) (Drug)
Rosuvastatin 20mg & Placebo & Placebo
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) (Drug)
DP-R207 20/10mg & Placebo & Placebo
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
干预措施: DP-R207 20/10mg (Drug)
DP-R207 20/10mg & Placebo & Placebo
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) (Drug)
DP-R207 20/10mg & Placebo & Placebo
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
干预措施: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) (Drug)
结局指标
主要结局
Percent change from baseline to 8 weeks in LDL-Cholesterol
时间窗: baseline and 8 weeks
次要结局
- Percent change from baseline to 8 weeks in lipid related blood test results(baseline and 8 weeks)
- Percent change from baseline to 4 weeks in lipid related blood test results(baseline and 4 weeks)
- Percent change from baseline to 4 weeks in LDL-Cholesterol(baseline and 4 weeks)
- Percentage of patients reaching treatment goals according to NCEP ATP III Guideline(week 4 and week 8)