Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension

Phase 4

Completed

• Conditions: Primary Hypertension; Secondary Hypertension
• Interventions: Drug: lisinopril, ACE-inhibitor

• Registration Number: NCT02184858
• Lead Sponsor: University Ghent

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 study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-10
• Study Start: 2014-06-25
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Primary Completion: 2017-05-08
• Status Verified: 2018-09
• Study Completion: 2018-09-17
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lisinopril	lisinopril, ACE-inhibitor	dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.

Primary Outcome Measures

Name	Time	Method
blood pressure	4 months

Secondary Outcome Measures

Name	Time	Method
Serum concentrations will be assessed after every dose titration	trough and 4 hours post dosing
Adverse events with assessment of specific blood parameters	up to 4 months	sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count

Trial Locations

Locations (1)

Department of Pediatrics and Medical Genetics; 🇧🇪 Ghent, Belgium