NCT01285544已完成4 期
Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- the percent change of LDL-C level
研究概览
简要总结
There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.
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
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
- •Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes
排除标准
- •therapy with any other investigational drug within 30 days of randomization,
- •history of hypersensitivity to HMG-CoA reductase inhibitors,
- •uncontrolled hypertension,
- •poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),
- •unstable angina or presented with new-onset myocardial infarction (within 6 months),
- •creatinine >2.5 mg/dl,
- •alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN,
- •history of malignancy or psychosis;
- •chronic liver disease,
- •drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.
研究组 & 干预措施
Lipinon-test formulation of atrovastain - 20mg
Experimental
干预措施: Atorvastatin (Lipinon) (Drug)
Lipitor- branded formuation of atorvastatin-20mg
Active Comparator
干预措施: Atorvastatin (Lipitor) (Drug)
结局指标
主要结局
the percent change of LDL-C level
时间窗: After taken medication for 8 weeks
次要结局
- the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP)(After taken medication for 8 weeks)
研究者
研究点 (1)
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