Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Ezetimibe; atorvastatin
Intervention description: Ezetimibe 10 mg once daily; atorvastatin 20 mg once daily
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin
      in participants with hypercholesterolemia who have not reached low density lipoprotein
      (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase
      inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with hypercholesterolemia who satisfy the following criteria:

               -  Participants who have used any of the following
                  3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (hereinafter
                  referred to as "statins") for 4 weeks or longer before the start of the
                  observation period and whose low density lipoprotein (LDL)-cholesterol level
                  during the treatment had not reached lipid management target

               -  Age: 20 years of age or older (at the time of obtaining informed consent)

               -  Sex: both males and females

               -  Inpatient/outpatient: Out-patient

        Exclusion Criteria:

          -  Participants for whom any of the following is applicable:

               -  Participants whose fasted triglyceride level measured at the start of the
                  observation period or the treatment period exceeds 500 mg/dL

               -  Participants with homozygous familial hypercholesterolemia

               -  Participants with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN)
                  measured at the start of the observation period or the treatment period.

               -  Participants with serious hepatic disorder, or participants with alanine
                  aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at
                  the start of the observation period or the treatment period.

               -  Participants with a history of hypersensitivity to any ingredient of ezetimibe
                  tablets or atorvastatin tablets

               -  Pregnant, nursing women, women who may be pregnant, or participants wishing to be
                  pregnant during the study.

               -  Participants who have discontinued use of serum lipid lowering agents for less
                  than 4 weeks at the start of the treatment period (8 weeks in the case of
                  probucol). (However, if the participant had taken a serum lipid lowering agent
                  before the test conducted at the start of the observation period, a period of
                  discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)

               -  Participants who are using cyclosporine from after the start of the observation
                  period

               -  Participants with a history of ezetimibe use

               -  Participants with hyperlipidemia associated with the following diseases:

                    -  Hypothyroidism

                    -  Obstructive gall bladder or biliary disease

                    -  Chronic renal failure

                    -  Pancreatitis

               -  Participants with hyperlipidemia associated with concomitant use of drugs having
                  adverse effect on serum lipids, etc

               -  Participants who have received an investigational drug within 4 weeks of the
                  start of the observation period

               -  Other participants deemed not appropriate for study entry by the investigator