Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-04-11 @ 4:56 PM
Study NCT ID:
NCT01152567
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2010-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-26', 'studyFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension', 'timeFrame': 'Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.'}], 'secondaryOutcomes': [{'measure': 'To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension', 'timeFrame': 'Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.'}, {'measure': 'To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan', 'timeFrame': 'Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.'}, {'measure': 'Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness', 'timeFrame': 'Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'ACE', 'ARB', 'real life data', 'CVD', 'cost effectiveness'], 'conditions': ['Hypertension', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '25211055', 'type': 'DERIVED', 'citation': 'Hasvold LP, Bodegard J, Thuresson M, Stalhammar J, Hammar N, Sundstrom J, Russell D, Kjeldsen SE. Diabetes and CVD risk during angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment in hypertension: a study of 15,990 patients. J Hum Hypertens. 2014 Nov;28(11):663-9. doi: 10.1038/jhh.2014.43. Epub 2014 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'The planned Study will be a retrospective study on the effect of ACE\'s vs. candesartan on cardiovascular events and on health economic effects in a "real life" setting in Sweden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient treated with ACE or candesartan in the period 1999 - 2007.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients found in electronic patient journals at the participating centres, who were prescribed either ACEis (ATC-C09A-B) or ARBs (C09C-D) for hypertension from 1 January 1999 - 31 December 2007. The first date of such a prescription starts the observation time and is called the index prescription.\n\nExclusion Criteria:\n\n* No history of cardiovascular disease.\n* Ongoing malignancy'}, 'identificationModule': {'nctId': 'NCT01152567', 'acronym': 'ARBACE', 'briefTitle': 'Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension', 'orgStudyIdInfo': {'id': 'NIS-CSE-ATA-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACE', 'description': 'Patients treated for hypertension with ACEs without CVD'}, {'label': 'Candesartan', 'description': 'Patients treated for hypertension with candesartan without CVD'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avesta', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.14274, 'lon': 16.16295}}, {'city': 'Älvdalen', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 61.22774, 'lon': 14.03935}}, {'city': 'Ängelholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.2428, 'lon': 12.86219}}, {'city': 'Åkersberga', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.47944, 'lon': 18.29967}}, {'city': 'Bengtsfors', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.02912, 'lon': 12.23207}}, {'city': 'Borlänge', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.4858, 'lon': 15.43714}}, {'city': 'Falun', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Farsta', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.24423, 'lon': 18.09088}}, {'city': 'Fritsla', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.55655, 'lon': 12.78457}}, {'city': 'Gagnef', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.59856, 'lon': 15.07745}}, {'city': 'Gävle', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Grängesberg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.07465, 'lon': 15.00784}}, {'city': 'Grycksbo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.68751, 'lon': 15.48507}}, {'city': 'Hallstahammar', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.61395, 'lon': 16.22846}}, {'city': 'Hägersten', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.30586, 'lon': 17.98719}}, {'city': 'Hässelby', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.7, 'lon': 16.91667}}, {'city': 'Hedemora', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.27973, 'lon': 15.98855}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Henån', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.23848, 'lon': 11.67598}}, {'city': 'Höllviken', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.40982, 'lon': 12.9558}}, {'city': 'Jarfalla', 'country': 'Sweden', 'facility': 'Research Site'}, {'city': 'Kil', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.50234, 'lon': 13.31277}}, {'city': 'Kolbäck', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.56516, 'lon': 16.23037}}, {'city': 'Kolsva', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.6, 'lon': 15.83333}}, {'city': 'Köping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.51404, 'lon': 15.99255}}, {'city': 'Leksand', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.7303, 'lon': 14.99994}}, {'city': 'Lidköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.50517, 'lon': 13.15765}}, {'city': 'Likenäs', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.61667, 'lon': 13.03333}}, {'city': 'Limhamn', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.58333, 'lon': 12.95}}, {'city': 'Ludvika', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.14959, 'lon': 15.18776}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Malung', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.68329, 'lon': 13.71542}}, {'city': 'Mora', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 61.00704, 'lon': 14.54316}}, {'city': 'Munka-Ljungby', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.25, 'lon': 12.96667}}, {'city': 'Norberg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.06505, 'lon': 15.92366}}, {'city': 'Sala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.91993, 'lon': 16.60655}}, {'city': 'Säter', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.34778, 'lon': 15.75051}}, {'city': 'Skanör', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.41667, 'lon': 12.85}}, {'city': 'Skepplanda', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.98333, 'lon': 12.2}}, {'city': 'Skinnskatteberg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.83028, 'lon': 15.69337}}, {'city': 'Skogås', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.21667, 'lon': 18.15}}, {'city': 'Skoghall', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32324, 'lon': 13.46552}}, {'city': 'Skövde', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'city': 'Skultuna', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.71667, 'lon': 16.41667}}, {'city': 'Smedjebacken', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.14181, 'lon': 15.41416}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stora Höga', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.01667, 'lon': 11.83333}}, {'city': 'Sunnansjö', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.21667, 'lon': 14.95}}, {'city': 'Sunne', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.83764, 'lon': 13.14302}}, {'city': 'Svärdsjö', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.74022, 'lon': 15.90173}}, {'city': 'Trollhättan', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}, {'city': 'Upplands Vasby', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.51839, 'lon': 17.91128}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Vansbro', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.50893, 'lon': 14.22458}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Niklas Lindarck', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Nordic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}