NCT00249249已完成3 期
Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Kowa Research Europe255 个研究点 分布在 4 个国家目标入组 830 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 830
- 试验地点
- 255
- 主要终点
- Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
研究概览
简要总结
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.
详细描述
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
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
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 (age 18-75 years).
- •Non-pregnant, non-lactating females
- •Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method.
- •Eligible and able to participate and have given informed consent
- •Must have been following a restrictive diet and does not eat or drink grapefruit
- •Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- •Available for every clinic visit, which will occur in the morning.
排除标准
- •Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia
- •Conditions which may cause secondary dyslipidemia.
- •Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- •History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
- •Liver injury
- •Impaired renal function
- •Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
- •Serum creatine kinase (CK) >5 x upper limit of the reference range (ULRR).
- •Uncontrolled hypothyroidism
- •Severe acute illness or severe trauma in the last 3 months
- •Major surgery, 3 months prior to Visit 1
- •Significant cardiovascular disease (CVD) prior to randomization
- •Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of >100 beats per minute at rest.
- •Left ventricular (LV) ejection fraction < 0.25
- •History of symptomatic cerebrovascular disease
- •Conditions at the discretion of the investigator
- •Known HIV infection
- •Poorly controlled or uncontrolled hypertension.
- •Known muscular or neuromuscular disease of any type
- •Neoplastic disease
- •Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
- •Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
- •Current or recent use of supplements known to alter lipid metabolism
- •Hypersensitivity reactions to other HMG-CoA reductase inhibitors
- •Concomitant medication not permitted
- •Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
- •Excessive obesity
- •Regular clinic attendance in the morning impractical
- •Signs of mental dysfunction or other factors likely to limit ability to cooperate
结局指标
主要结局
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
时间窗: Baseline to 12 weeks
次要结局
- Percent Change From Baseline in Total Cholesterol (TC)(Baseline to 12 Weeks)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)(Baseline to 12 weeks)
- TC:HDL-C Ratio(12 weeks)
- Triglycerides (TG)(12 weeks)
- Non-HDL:HDL Ratio(12 weeks)
- Apolipoprotein B (Apo B)(12 weeks)
- Apolipoprotein-A1 (Apo-A1)(12 weeks)
- Apo-B:Apo-A1 Ratio(12 weeks)
- High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks(12 weeks)
- Oxidized LDL at 12 Weeks(12 weeks)
- National Cholesterol Education Program [NCEP]LDL-C Target Attainment(up to 12 weeks)
研究者
研究点 (255)
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