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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT03550859
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥ 19 years
2. Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
3. Diagnosed with hypertension
4. Written informed consent
5. Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
Exclusion Criteria:
1. Type I diabetes
2. Uncontrolled diabetic patients with HbA1c \> 10% at screening
3. Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization
4. Calculated LDL-C ≥ 160 mg/dL at randomization
5. Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
6. Heart failure patients with NYHA class IV
7. Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
8. Patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention)
9. Patients taking immunosuppressive drugs
10. Patients undergoing eGFR \<30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
11. Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
12. Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
13. Patients who are pregnant or planning to become pregnant
14. Contraindications stated in the SPC of telmisartan or rosuvastatin
15. Those participating in other clinical trials for investigational products at screening
16. Patients deemed to be ineligible to participate in the trial by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03550859
Study Brief:
Protocol Section:
NCT03550859