Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Simvastatin; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653523

P05457

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Ezetimibe + Simvastatin

Experimental group

Description:

Ezetimibe 10 mg + Simvastatin 20 mg

Treatment:

Drug: Simvastatin

Drug: Ezetimibe