Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00871351
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00871351
Study Brief:
Protocol Section:
NCT00871351