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 @ 11:55 AM
Ignite Modification Date:
2025-12-24 @ 11:55 AM
NCT ID:
NCT03446261
Eligibility Criteria:
Inclusion Criteria:
1. Aged 19 to 70 years
2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
3. Written informed consent
Exclusion Criteria:
1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
2. Uncontrollable diabetes with HbA1c ≥ 8.5%
3. Fasting LDL-C ≤ 70 mg/dL
4. Fasting triglyceride ≥ 400 mg/dL
5. Total cholesterol ≥ 300 mg/dL
6. History of muscular disease or rhabdomyolysis due to use of statin
7. Hypersensitive to rosuvastatin or ezetemibe
8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
① Severe renal disease (estimated GFR(MDRD) \< 30mL/min/1.73m2)
② ALT, AST \> 3x ULN or history of active liver disease
③ CPK \> 3x ULN
9. Administration of other investigational products within 30 days prior to screening visit
10. Other than the above who is deemed to be ineligible to participate in the trial by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT03446261
Study Brief:
Protocol Section:
NCT03446261