Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00837720
Status:
COMPLETED
Last Update Posted:
2009-02-06
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Atacand® (Candesartan) in Daily Medical Practice
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-05', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure reduction', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence and reasons of treatment discontinuation', 'timeFrame': '12 weeks'}, {'measure': "Patient treatment satisfaction (using 5-point answering scale) as the measure of the patient's overall tolerance", 'timeFrame': '12 weeks'}, {'measure': 'Physician overall evaluation of the therapy (using 5-point answering scale)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'blood pressure', 'Atacand®', 'candesartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This open label, non-interventional study is to show the efficacy of antihypertensive treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients (outpatient or hospitalised) in whom Atacand is indicated according to the current Summary of product characteristics (SPC)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* a patient with arterial hypertension who has been prescribed Atacand according to physician's judgement, irrespective of the inclusion in the study\n\nExclusion Criteria:\n\n* hypersensitivity to candesartan or any other ingredient of Atacand\n* liver function impairment and/or cholestasis\n* severe renal insufficiency\n* woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation"}, 'identificationModule': {'nctId': 'NCT00837720', 'briefTitle': 'Evaluation of Atacand® (Candesartan) in Daily Medical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 12-Week Open-Label Non-Interventional Evaluation of Atacand® (Candesartan) Efficacy, Tolerability, Compliance and Treatment Satisfaction in Patients With Arterial Hypertension', 'orgStudyIdInfo': {'id': 'NIS-CSI-ATA-2005/1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rok Accetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager', 'oldOrganization': 'AstraZeneca'}}}}