Clinical trial NCT01386853 (phase 3, status: unknown status)
Conditions: hyperlipidemia
ICD codes: E78.2, E78.49, E78.5
Drugs: pitavastatin, atorvastatin
SMILES: O[C@H](C[C@H](O)\C=C\C1=C(N=C2C=CC=CC2=C1C1=CC=C(F)C=C1)C1CC1)CC(O)=O, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1
Eligibility 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.