Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 28
- 主要终点
- Number of Patients Attaining NCEP LDL-C Target at Week 16
研究概览
简要总结
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
详细描述
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed NK-104-304 (NCT 00309738)
- •Hypercholesterolemia or combined dyslipidemia
- •2 or more risk factors for coronary heart disease (CHD)
排除标准
- •Withdrawn or terminated from NK-104-304 (00309738)
研究组 & 干预措施
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
干预措施: pitavastatin (Drug)
Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
干预措施: simvastatin (Drug)
结局指标
主要结局
Number of Patients Attaining NCEP LDL-C Target at Week 16
时间窗: 16 weeks
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Number of Patients Attaining NCEP LDL-C Target at Week 44
时间窗: 44 Weeks
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
次要结局
- Percent Change From Baseline in LDL-C(Baseline to 44 weeks)