Status:
COMPLETED
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Primary Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 lipopro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00871351
Start Date
February 1 2009
End Date
May 1 2010
Last Update
May 23 2024
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