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

Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02184858

Acronym

Lisi-ped

Enrollment

Registered

2014-07-09

Start date

2014-06-25

Completion date

2018-09-17

Last updated

2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension, Secondary Hypertension

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.

Interventions

DRUGlisinopril, ACE-inhibitor

Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
blood pressure	4 months

Secondary

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026