NCT01710007 2011.

Study name	Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Methods	Historically controlled trial 4 week washout period of all previous lipid lowering drugs 12 week study
Participants	Females or males aged between 20 and 80 years Included criteria: Subjects who meet All of the following diagnosis at screening visit:Primary hypercholesterolaemia or combined dyslipidaemia TC ≥ 220 mg/dL or LDL‐C ≥ 130 mg/dL TG < 400 mg/dL Subjects who is willing and able to provide ICF. Exclusion criteria: Females who are pregnant, breast‐feeding or intent to be pregnant during study period, or those of childbearing potential not using effective contraception Subject with documented homozygous familial hypercholesterolaemia Subject with documented HIV Subject with documented hypothyroidism and inadequate treatment judged by investigator Subjects with unstable cardiovascular disease (CVD) prior to randomisation Subjects with hepatic or biliary disorders, such as acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs. Subjects with the following lab data at screening visit:serum creatine kinase (CK) > 5 x upper limit of normal (ULN) ALT or AST of > 3 x ULN serum creatinine ≥ 1.5 mg/dL HbA1c > 8.0% Subject with the following past histories:hypersensitivity to statins or any other ingredients of study drugs resistant to statins treatment Use of any lipid‐lowering agents within 4 weeks prior to the initiation of study treatment Use of any investigational product within 4 weeks prior to screening Any unstable concomitant disease or clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
Interventions	1PC002 (Pitavastatin) 2 mg/day
Outcomes	Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides
Starting date	October 18, 2012
Contact information	Orient Pharma Co., Ltd.
Notes

ALT: Alanine aminotransferase

AST: Aspartate aminotransferase

CK: Creatine kinase

CVD: Cardiovascular disease

HbA1c: Haemoglobin A1c

HDL‐C: High density lipoprotein cholesterol

HIV: Human immunodeficiency virus

ICF: Informed consent form

LDL‐C: Low density lipoprotein cholesterol

PCI: Percutaneous coronary intervention

ST: End of S and start of T wave between ventricular depolarisation and repolarization electrocardiogram

TC: Total cholesterol

TG: Triglycerides

ULN: Upper limit of normal