Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.