Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: 1PC002; Lipitor
Intervention description: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.; Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
Intervention MeSH terms: Atorvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: HMG-CoA reductase inhibitors

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females or males aged between 20 and 80 years.

          2. Subjects who meet All of the following diagnosis at screening visit:

               -  Primary hypercholesterolemia or combined dyslipidemia

               -  TC ≥ 220 mg/dL or LDL-C ≥ 130 mg/dL

               -  TG < 400 mg/dL

          3. Subjects who is willing and able to provide ICF.

        Exclusion Criteria:

          1. Females who are pregnant, breast-feeding or intent to be pregnant during study period,
             or those of childbearing potential not using effective contraception.

          2. Subject with documented homozygous familial hypercholesterolemia.

          3. Subject with documented HIV.

          4. Subject with documented hypothyroidism and inadequate treatment judged by
             investigator.

          5. Subjects with unstable cardiovascular disease (CVD) prior to randomization.

          6. Subjects with hepatic or biliary disorders, such as acute hepatitis, acute
             exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice.

          7. Any condition which might significantly alter the absorption, distribution,
             metabolism, or excretion of study drugs.

          8. 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%

          9. Subject with the following past histories:

               -  hypersensitivity to statins or any other ingredients of study drugs

               -  resistant to statins treatment

         10. Use of any lipid-lowering agents within 4 weeks prior to the initiation of study
             treatment.

         11. Use of any investigational product within 4 weeks prior to screening.

         12. 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.