Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a prospective, active-controlled, double-blind, randomized, parallel, and
      multi-center study. To target 150 evaluable subjects, approximately 200 Taiwanese patients
      with primary hypercholesterolemia or combined dyslipidemia will be enrolled in this study.

      After providing the written inform consent, patients will undergo a complete physical
      examination, vital sign (brachial BP / HR), medical history, and lab assessment, including
      fasting serum LDL-C, TC, HDL-C, TG, and non-HDL. They should not take any hypolipidemic drugs
      for at least 4 weeks prior to initiation of study treatment. All eligible subjects will be
      randomized into 2 groups in a 1:1 ratio to receive either 2 mg 1PC002 or 10 mg atorvastatin
      once daily for 12 weeks.

        -  Study Group: 1PC002 1 cap. q.d. p.o.

        -  Control Group: Atorvastatin 1 cap. q.d. p.o.

      After entering the baseline visit, lipid profiles (including fasting serum LDL-C, TC, HDL-C,
      TG, non-HDL, Apo A1, Apo B and Apo B / Apo A1 ratio), hs-CRP, eGFR, spot urinary albumin /
      creatinine ratio (ACR) and central BP values will be obtained at baseline, Week 4 and Week 12
      for evaluating the effectiveness of study drugs and for any possible changes in laboratory
      data. Non-HDL value will be calculated by subtracting HDL-C from TC. Moreover, serum Cystatin
      C, another biomarker of renal function, will also be assessed at baseline and Week 12.

      For monitoring the safety, biochemical and hematological assessment will be performed at
      baseline, Week 4 and 12. Additional liver function and CK test will be conducted at Week 8.
      The occurring AE(s) and SAE will be followed until resolution or the event is considered
      stable.
    

Intervention name(s): 1PC002; Lipitor
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Pitavastatin; Atorvastatin
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HMG-CoA reductase inhibitors