Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, Pitavastatin, Atorvastatin
Brief summary
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.
Interventions
DRUGPitavastatin
2 mg QD
DRUGAtorvastatin
10 mg QD
Sponsors
Tai Tien Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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/m2. * 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 2. * 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 2. * Any major surgery within 3 months prior to Visit 2. * Female patient who is lactating, being pregnant or plans to become pregnant. * Patient with conditions judged by the investigator as unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of LDL-C | Baseline to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Taiwan
Contacts
Primary ContactJasmine Chao
Outcome results
None listed