NCT02184858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

June 25, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2.9 years

First QC Date

June 10, 2014

Last Update Submit

September 18, 2018

Conditions

Primary HypertensionSecondary Hypertension

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    4 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

lisinopril

EXPERIMENTAL

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

Drug: lisinopril, ACE-inhibitor

Interventions

lisinopril, ACE-inhibitorDRUG

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

lisinopril

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics and Medical Genetics

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Sandra L, Degraeuwe E, De Bruyne P, De Baere S, Croubels S, Van Bocxlaer JFP, Raes A, Vande Walle J, Gasthuys E, Vermeulen A. Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function. Br J Clin Pharmacol. 2024 Feb;90(2):504-515. doi: 10.1111/bcp.15936. Epub 2023 Nov 10.

    PMID: 37864281DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

LisinoprilAngiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Johan Vande Walle, PhD MD

    Ghent University, Department of Pediatrics and Medical Genetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

July 9, 2014

Study Start

June 25, 2014

Primary Completion

May 8, 2017

Study Completion

September 17, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

BE(1)