Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

Open-label, Long-term Study of Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors

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.

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