Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tai Tien Pharmaceuticals Co., Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium; Pitavastatin

Criteria

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.