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

Official Title: “Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia”

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.

Intervention(s) in this Clinical Trial

• Drug: Ezetimibe
  • 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
• Drug: Atorvastatin
  • 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
• Drug: Atorvastatin
  • 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
• Drug: Rosuvastatin
  • 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ezetimibe + Atorvastatin
  • Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
• Active Comparator: Atorvastatin
  • Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
• Active Comparator: Rosuvastatin
  • Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Primary Measures

• Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
  • Time Frame: End of Week 4 to Week 16 or discontinuation
    Safety Issue?: No

Secondary Measures

• Percent Change in LDL-C
  • Time Frame: End of washout period to Week 16 or discontinuation
    Safety Issue?: No
• Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
  • Time Frame: Week 16 or discontinuation
    Safety Issue?: No
• Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
  • Time Frame: End of Week 4 to Week 16 or discontinuation
    Safety Issue?: No
• Percent Change in Total Lipids and Hs-CRP
  • Time Frame: End of washout to Week 16 or discontinuation
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00871351

Study ID Number: P06027

ClinicalTrials.gov Identifier: NCT00871351

Health Authority: Japan: Ministry of Health, Labor and Welfare