Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its
active compound, pitavastatin has recently been approved by US FDA for indications of primary
hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic
properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not
depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of
1PC002 administered for 12 weeks is non-inferior to atorvastatin.