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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02184858
Eligibility Criteria:
Inclusion Criteria:
* Parental consent must be granted
* Patient age: 1y - 18 y
* Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
* No reversible cause found on diagnostic work-up for hypertension
* Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension
Exclusion Criteria:
* Pregnancy
* Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
* Following abnormal laboratory values: Hyperkaliemia (serum potassium \> 5.3mmol/L); Anemia (hemoglobin \< 8g/dL); AST or ALT \> 3 times the upper limit of reference range; Total bilirubin \> 3 times the upper limit of reference range
* Abnormalities of the oral cavity that can influence intake of medication
* Known sensitivity to ACE-inhibitors
* Known lactose intolerance
* History of angioedema
* Unilateral or bilateral stenosis of the renal artery
* Diagnosis of heart failure (NYHA Class II-IV)
* History of coarctation of the aorta
* Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT02184858
Study Brief:
Protocol Section:
NCT02184858