Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-29 @ 12:51 PM
Study NCT ID:
NCT00202592
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S90652 in Paediatric Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinical safety assessed from the patient's (parents) complaints and clinical follow-up"}], 'secondaryOutcomes': [{'measure': 'Blood pressure'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '30 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy\n\nExclusion Criteria:\n\n* Poorly controlled hypertension\n* Girls with signs of pubescence'}, 'identificationModule': {'nctId': 'NCT00202592', 'briefTitle': 'S90652 in Paediatric Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children - 24 Months', 'orgStudyIdInfo': {'id': 'CL2-90652-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Perindopril', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Patrick Niaudet, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Necker-Enfants Malades, Paris, France'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicaltrials.servier.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After Marketing Authorisation in EEA or US if the study is used for the approval.', 'ipdSharing': 'YES', 'description': 'Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).\n\nThey can ask all interventional clinical studies in patients:\n\n* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).\n* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.', 'accessCriteria': 'Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}