Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

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.

Timeline

Start

2011-11

Primary completion

2012-09

Completion

2012-11

Drugs

Indications