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:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00934258
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 20-79 years with definite DM or atherosclerotic vascular diseases with metabolic syndrome, defined as the presence of three or more of the following risk factors:
* abdominal obesity (waist circumference \> 90 cm in men or \> 80 cm in women),
* triglycerides \> 150 mg/dL, HDL-cholesterol \< 40 mg/dL in men or \< 50 mg/dL in women,
* blood pressure \> 130/85 mm Hg, or
* fasting glucose \> 100 mg/dL).
* Those who are qualified for lipid lowering therapy according to the Taiwanese national guidelines (LDL-C 130-190 mg/dL or TG 200-500 mg/dL with HDL-C \< 40 mg/dL or TC/HDL-C \> 5).
Exclusion Criteria:
* Any known contraindications to statin or fibrate therapy,
* Previous intolerance to statin or fibrate in low or high doses,
* Liver enzyme levels more than 3 times the upper limit of normal,
* Pregnancy or breastfeeding,
* Nephrotic syndrome,
* Uncontrolled diabetes mellitus (HbA1c \> 9),
* Uncontrolled hypothyroidism,
* Plasma LDL-C level higher than 190 mg/dL or triglyceride level higher than 500 mg/dL,
* Coronary heart disease event or revascularisation within a month,
* Congestive heart failure (New York Heart Association classification IIIb or IV),
* Hemodynamically important valvular heart disease,
* Gastrointestinal conditions affecting absorption of drugs,
* Treatment with other drugs that seriously affect the pharmacokinetics of statins or fibrate,
* Unexplained creatine phosphokinase concentrations six or more times the upper limit of normal,
* Life-threatening malignancy,
* Treatment with immuno suppressive or other lipid lowering drugs.
* Patients previously treated with monotherapy with statins or fibrates will be qualified if they have not already had titration to a dose higher than the equivalent of 5 mg/d of rosuvastatin or 160 mg/d of SFC fenofibrate.
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT00934258
Study Brief:
Protocol Section:
NCT00934258