Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-17 @ 6:47 PM
Study NCT ID:
NCT02184858
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2014-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-07-08', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Serum concentrations will be assessed after every dose titration', 'timeFrame': 'trough and 4 hours post dosing'}, {'measure': 'Adverse events with assessment of specific blood parameters', 'timeFrame': 'up to 4 months', 'description': 'sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Hypertension', 'Secondary Hypertension']}, 'referencesModule': {'references': [{'pmid': '37864281', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parental consent must be granted\n* Patient age: 1y - 18 y\n* Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004\n* No reversible cause found on diagnostic work-up for hypertension\n* Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension\n\nExclusion Criteria:\n\n* Pregnancy\n* 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\n* 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\n* Abnormalities of the oral cavity that can influence intake of medication\n* Known sensitivity to ACE-inhibitors\n* Known lactose intolerance\n* History of angioedema\n* Unilateral or bilateral stenosis of the renal artery\n* Diagnosis of heart failure (NYHA Class II-IV)\n* History of coarctation of the aorta\n* Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication'}, 'identificationModule': {'nctId': 'NCT02184858', 'acronym': 'Lisi-ped', 'briefTitle': 'Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.', 'orgStudyIdInfo': {'id': 'EC project number: 2012/498'}, 'secondaryIdInfos': [{'id': '2012-002927-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lisinopril', 'description': 'dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.', 'interventionNames': ['Drug: lisinopril, ACE-inhibitor']}], 'interventions': [{'name': 'lisinopril, ACE-inhibitor', 'type': 'DRUG', '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', 'armGroupLabels': ['lisinopril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Department of Pediatrics and Medical Genetics', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Johan Vande Walle, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ghent University, Department of Pediatrics and Medical Genetics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}