NCT00309738已完成3 期
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
Kowa Research Europe32 个研究点 分布在 4 个国家目标入组 355 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 32
- 主要终点
- Percent Change From Baseline in LDL-C
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females (18-75 years of age)
- •At least two cardiovascular disease risk factors
- •Must have been following a restrictive diet
- •Diagnosis of primary hypercholesterolemia or combined dyslipidemia
排除标准
- •Homozygous familial hypercholesterolemia
- •Conditions which may cause secondary dyslipidemia
- •Uncontrolled diabetes mellitus
- •Abnormal pancreatic, liver or renal function
- •Abnormal serum creatine kinase (CK) above the pre-specified level
研究组 & 干预措施
Pitavastatin 4 mg QD
Experimental
Pitavastatin 4 mg once daily
干预措施: pitavastatin (Drug)
Simvastatin 40 mg QD
Active Comparator
Simvastatin 40 mg once daily
干预措施: simvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C
时间窗: 12 weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
次要结局
- Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)(12 weeks)
研究者
研究点 (32)
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