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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03403556
Eligibility Criteria:
* ≥ 40 and \< 75 years of age at the time of informed consent
* Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening
* HbA1c ≥ 6% and \< 10% in screening
* Body mass index (BMI) ≤ 35kg/m2 in screening
* Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period
* Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs
Exclusion Criteria:
* Type 1 diabetes
* Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening
* Heavy drinking \> 210g per week in screening
* Estimated GFR \< 30mL/min/1.73m2 using the CKD-EPI formula in screening
* Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening
* Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening
* Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL
\* Can be enrolled after 4 week-washout
* Having used thiazolidinedione drugs in the last 3 months before screening
* Taking cyclosporine concomitantly
* Positive HIV test in screening
* Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator
* Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin
* Hypersensitive to statin and ezetimibe
* Having endocrine or metabolic disease known to affect serum lipids or lipoproteins
* Uncontrolled diabetes (HbA1c ≥ 10%)
* Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN)
* Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening
* Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders
* Insulin-treated
* Taking other IPs in the last 30 days before screening
* Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period
* Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial
* Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
74 Years
Study:
NCT03403556
Study Brief:
Protocol Section:
NCT03403556