Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

P06027

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

2009-02-01

2010-05-01

2010-05-01

Completed

Early phase I

125

Inclusion Criteria: * atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C \<160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C \<140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C \<120 mg/dL; and for participants with history of coronary artery disease - LDL-C \<100 mg/dL. * outpatient men or women, age 20 years and older Exclusion Criteria: * fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL. * homozygous familial hypercholesterolemia. * creatine phosphokinase (CPK) \>2 times the upper limit of normal (X ULN) at start of washout or treatment period. * glycosylated hemoglobin (HbA1c) \>=8％ at start of washout or treatment period. * severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X ULN at start of washout or treatment period. * hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets. * pregnant or lactating * discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.) * cyclosporine treatment * hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis. * hyperlipidemia associated with drug administration that causes adverse serum lipid effects. * participation in a clinical study within 4 weeks of washout * cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 125, 'type': 'ACTUAL'}}

2024-05-23