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Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension (Lisi-ped)

Primary Purpose

Primary Hypertension, Secondary Hypertension

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

lisinopril, ACE-inhibitor

About this trial

This is an interventional treatment trial for Primary Hypertension

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Department of Pediatrics and Medical Genetics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lisinopril

Arm Description

dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.

Outcomes

Primary Outcome Measures

blood pressure

Secondary Outcome Measures

Serum concentrations will be assessed after every dose titration

Adverse events with assessment of specific blood parameters

sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count

Full Information

NCT ID

NCT02184858

First Posted

June 10, 2014

Last Updated

September 18, 2018

Sponsor

University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT02184858

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 25, 2014 (Actual)

Primary Completion Date

May 8, 2017 (Actual)

Study Completion Date

September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ghent

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hypertension, Secondary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lisinopril

Arm Type

Experimental

Arm Description

dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.

Intervention Type

Drug

Intervention Name(s)

lisinopril, ACE-inhibitor

Intervention Description

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

Primary Outcome Measure Information:

Title

blood pressure

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Serum concentrations will be assessed after every dose titration

Time Frame

trough and 4 hours post dosing

Title

Adverse events with assessment of specific blood parameters

Description

sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count

Time Frame

up to 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johan Vande Walle, PhD MD

Organizational Affiliation

Ghent University, Department of Pediatrics and Medical Genetics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatrics and Medical Genetics

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

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

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