Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percent change in Low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with primary hyperlipidemia or mixed dyslipidemia
- •Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII
- •Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation
排除标准
- •Homozygous familial hypercholesterolemia;
- •Any conditions which may cause secondary dyslipidemia.
- •Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >9%
研究组 & 干预措施
NK-104-CR
NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
干预措施: NK-104-CR (Drug)
NK-104-CR
NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
干预措施: Placebo (for Livalo® IR) (Drug)
Livalo® IR
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
干预措施: Livalo® IR (Drug)
Livalo® IR
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
干预措施: Placebo (for NK-104-CR) (Drug)
结局指标
主要结局
Percent change in Low-density lipoprotein cholesterol (LDL-C)
时间窗: Baseline to Week 12 endpoint
次要结局
未报告次要终点