Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 545
- 试验地点
- 59
- 主要终点
- Change From Baseline in LDL-C
研究概览
简要总结
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
详细描述
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 65 years of age
- •Primary hypercholesterolemia
- •Combined dyslipidemia
- •Completed study NK-104-306 (NCT00257686)
排除标准
- •Failed to complete study NK-104-306(NCT00257686)
研究组 & 干预措施
Pitavastatin 2 mg QD
Pitavastatin 2 mg once daily
干预措施: Pitavastatin (Drug)
Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
干预措施: Pitavastatin (Drug)
结局指标
主要结局
Change From Baseline in LDL-C
时间窗: Baseline to 60 weeks
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
次要结局
- Change From Baseline in Total Cholesterol(Baseline to 60 weeks)