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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT03073018
Eligibility Criteria:
Inclusion Criteria:
* Persistent microalbuminuria (urinary albumin excretion \>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples)
* No hypertension (RR \<160/100 mm Hg, no anti-hypertensive medication)
* No hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)
Exclusion Criteria:
* Creatinine clearance \>60% of the normal age-adjusted value
* Serum potassium \>5.5 mmol/L
* History of chronic liver disease
* Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal
* Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists
* Use of insulin
* Previously documented allergy or intolerance to study drugs
* Pregnant or nursing women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03073018
Study Brief:
Protocol Section:
NCT03073018