Status:
COMPLETED
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
Lead Sponsor:
University Ghent
Conditions:
Primary Hypertension
Secondary Hypertension
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02184858
Start Date
June 25 2014
End Date
September 17 2018
Last Update
September 20 2018
Active Locations (1)
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1
Department of Pediatrics and Medical Genetics
Ghent, Belgium, 9000