Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Ezetimibe; Atorvastatin; Atorvastatin; Rosuvastatin
Intervention description: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16); 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16); 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16); 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and
      ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose
      low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target
      value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or
      changing to rosuvastatin 2.5 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week
             washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached
             the following lipid management target values during treatment: Category I (low-risk
             group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group)
             with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III
             (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for
             participants with history of coronary artery disease - LDL-C <100 mg/dL.

          -  outpatient men or women, age 20 years and older

        Exclusion Criteria:

          -  fasted triglyceride level at the start of washout or treatment period exceeding 400
             mg/dL.

          -  homozygous familial hypercholesterolemia.

          -  creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of
             washout or treatment period.

          -  glycosylated hemoglobin (HbA1c) >=8％ at start of washout or treatment period.

          -  severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine
             aminotransferase (ALT) >2X ULN at start of washout or treatment period.

          -  hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.

          -  pregnant or lactating

          -  discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment
             period (however, if participant had taken atorvastatin 10 mg before the test conducted
             at the start of the observation period, a period of discontinuation of 27 days is
             allowed.)

          -  cyclosporine treatment

          -  hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary
             disease, chronic renal failure, and/or pancreatitis.

          -  hyperlipidemia associated with drug administration that causes adverse serum lipid
             effects.

          -  participation in a clinical study within 4 weeks of washout

          -  cancer or cancer history within previous 5 years, except for successfully treated
             basal cell carcinoma of the skin.