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

September 18, 2018 updated by: University Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Department of Pediatrics and Medical Genetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lisinopril
dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 4 months
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Johan Vande Walle, PhD MD, Ghent University, Department of Pediatrics and Medical Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2014

Primary Completion (Actual)

May 8, 2017

Study Completion (Actual)

September 17, 2018

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC project number: 2012/498
  • 2012-002927-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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