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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT00506961
Eligibility Criteria:
Inclusion Criteria:
1. Male and female between the ages of 20-75 years.
2. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
3. Diagnosed with type 2 diabetes mellitus.
4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL
5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable).
6. All patients give written informed consent.
Exclusion Criteria:
1. A history of hypersensitivity to statins.
2. A history of rhabdomyolysis or hereditary muscle disorders.
3. Insulin-treated patients.
4. Patient with any conditions of acute or chronic pancreatitis.
5. Creatine kinase ≧3-fold upper limit of normal (ULN).
6. Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN).
7. Overt proteinuria (repeat spot urine protein \>300mg/dl by dipstick method).
8. Patients are taking cyclosporine.
9. A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia.
10. Patients with alcohol and drug abuse in past 3 years.
11. Serious or unstable medical or psychological conditions.
12. Hypothyroidism (TSH \> 5 μIU/mL).
13. In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00506961
Study Brief:
Protocol Section:
NCT00506961