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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT00199927
Eligibility Criteria:
Inclusion Criteria:
* age \>16 years
* hypertension, defined as a systolic or diastolic blood pressure \> 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
* creatinine clearance \>20 ml/min/1.73m2 (with variation of less than 30% in the 3 months prior to study entry)
* urinary protein excretion rate persistently \> 1 g/24 hours (average of at least two measurements in two urine collections two weeks apart) without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
* written informed consent
Exclusion criteria:
* specific contraindication to statin therapy because of a previous coronary event or serum LDL-cholesterol levels \> 190 mg/dL despite a low cholesterol (\<200 mg/day) diet and a saturated fatty acid in take less than 7% of total calories will not be included
* chronic treatment with corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs
* acute myocardial infarction or cerebrovascular accident in the six months preceding the study - severe uncontrolled hypertension (diastolic blood pressure \>115 and/or systolic blood pressure \>220 mmHg)
* evidence or suspicion of renovascular disease, obstructive uropathy, type 1 diabetes mellitus, vasculitides, cancer
* elevated serum aminotransferase concentrations - chronic cough
* history of poor tolerance or allergy to ACEi, ATA or statins
* drug or alcohol abuse
* pregnancy, breast feeding and ineffective contraception
* legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT00199927
Study Brief:
Protocol Section:
NCT00199927