Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
- Registration Number
- NCT01386853
- Lead Sponsor
- Tai Tien Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitavastatin Pitavastatin - Atorvastatin Atorvastatin -
- Primary Outcome Measures
Name Time Method The change of LDL-C Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Changhua Christian Hospital
🇨🇳Chang-hua, Taiwan
Chang Gung Memorial Hospital-LinKou
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan