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

• 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 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.

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

Details

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

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