NCT01386853Unknown3 期
A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
Tai Tien Pharmaceuticals Co., Ltd.6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- The change of LDL-C
研究概览
简要总结
This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 20 years old and < 75 years old.
- •Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
- •Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
- •Patient with at least one of the following description (NCEP ATP III guideline).
- •Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
排除标准
- •Patient who has participated in other investigational studies within 3 months.
- •Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
- •Patient is taking any medication or food that is prohibited by the study.
- •Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
- •Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
- •Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
- •Patient with TG > 400 mg/dL.
- •Excessive obesity defined as BMI above 35 kg/m
- •Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
- •Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio > 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
- •Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
- •Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
- •Patient with CK level > 5 × ULRR at any time point between Visit 1 and Visit
- •Patient with poorly controlled diabetes mellitus (HbA1c > 9.0%) or patient with severe hypertension (> 180 mmHg for systolic or > 120 mmHg in diastolic blood pressure).
- •Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
- •Patient has significant alcohol consumption (> 65 mL pure alcohol) within 48 hours before Visit
- •Any major surgery within 3 months prior to Visit
- •Female patient who is lactating, being pregnant or plans to become pregnant.
- •Patient with conditions judged by the investigator as unsuitable for the study.
研究组 & 干预措施
Pitavastatin
Experimental
干预措施: Pitavastatin (Drug)
Atorvastatin
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
The change of LDL-C
时间窗: Baseline to 12 weeks
次要结局
- The proportion of patients achieving LDL-C < 100 mg/dL; the changes of HDL-C, TG, non-HDL-C, Apo A1 and Apo B, fasting plasma glucose, fasting insulin level, insulin resistance by the HOMA-IR, HbA1c, free fatty acid, and ADMA(Baseline to 4 weeks and 12 weeks)
研究者
研究点 (6)
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