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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Simvastatin

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