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NCT Number: NCT02184858

Dose Titration 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.

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Secondary Hypertension Vascular Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics and Medical Genetics

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lisinopril, ACE-inhibitor

Drug

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 outcomes

  1. blood pressure

    Time frame: 4 months

Secondary outcomes

  1. Serum concentrations will be assessed after every dose titration

    Time frame: trough and 4 hours post dosing

  2. 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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Acronym: Lisi-ped

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jul 9, 2014
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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