Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Ezetimibe; Simvastatin
Intervention description: Ezetimibe 10 mg once daily; Simvastatin 20 mg daily
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin
      in patients 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:

          -  Patients with hypercholesterolemia who satisfy the following criteria:

               -  Patients who have used any of the following HMG-CoA reductase inhibitors
                  (hereinafter referred to as "statins") for 4 weeks or longer before the start of
                  the observation period and whose LDL-cholesterol level during the treatment had
                  not reached lipid management target indicated below

               -  Age: 20 years of age or older (at the time of obtaining informed consent)

               -  Sex: both males and females

               -  Inpatient/outpatient: Out-patients

        Exclusion Criteria:

          -  Patients for whom any of the following is applicable:

               -  Patients whose fasted triglyceride level measured at the start of the observation
                  period or the treatment period exceeds 500 mg/dL

               -  Patients with homozygous familial hypercholesterolemia

               -  Patients with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN)
                  measured at the start of the observation period or the treatment period.

               -  Patients with serious hepatic disorder, or patients with alanine aminotransferase
                  (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the
                  observation period or the treatment period.

               -  Patients with a history of hypersensitivity to any ingredient of ezetimibe
                  tablets or simvastatin tablets

               -  Pregnant, nursing women, women who may be pregnant, or patients wishing to be
                  pregnant during the study.

               -  Patients 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 patient 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.)

               -  Patients who are using cyclosporine from after the start of the observation
                  period

               -  Patients who are using any of the following drug from after the start of the
                  observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate

               -  Patients with a history of ezetimibe use

               -  Patients with hyperlipidemia associated with the following diseases:

                    -  Hypothyroidism

                    -  Obstructive gall bladder or biliary disease

                    -  Chronic renal failure

                    -  Pancreatitis

               -  Patients with hyperlipidemia associated with concomitant use of drugs having
                  adverse effect on serum lipids, etc

               -  Patients who have received an investigational drug within 4 weeks of the start of
                  the observation period

               -  Other patients deemed not appropriate for study entry by the investigator