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

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ClinicalTrials.gov Identifier: NCT02184858
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Ghent

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.

Condition or disease Intervention/treatment Phase
Primary Hypertension Secondary Hypertension Drug: lisinopril, ACE-inhibitor Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.
Actual Study Start Date : June 25, 2014
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

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




Primary Outcome Measures :
  1. blood pressure [ Time Frame: 4 months ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184858


Locations
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Belgium
Department of Pediatrics and Medical Genetics
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Johan Vande Walle, PhD MD Ghent University, Department of Pediatrics and Medical Genetics

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02184858     History of Changes
Other Study ID Numbers: EC project number: 2012/498
2012-002927-14 ( EudraCT Number )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Hypertension
Neoplasm Metastasis
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs