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

Primary Hypertension Clinical Trial

— Lisi-ped  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184858
• Other study ID #: EC project number: 2012/498
• Secondary ID: 2012-002927-14
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2014
• Est. completion date: September 17, 2018

Study information

• Verified date: September 2018
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 17, 2018
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Neoplasm Metastasis
• Primary Hypertension
• Secondary Hypertension

Intervention

Drug:
• lisinopril, 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

Locations

Country	Name	City	State
Belgium	Department of Pediatrics and Medical Genetics	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		4 months
Secondary	Serum concentrations will be assessed after every dose titration		trough and 4 hours post dosing
Secondary	Adverse events with assessment of specific blood parameters	sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count	up to 4 months