Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension
ARBACE
1 other identifier
observational
50,000
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Shorter than P25 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 18, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 27, 2011
September 1, 2011
5 months
June 18, 2010
September 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension
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.
Secondary Outcomes (3)
To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension
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.
To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan
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.
Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness
Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year
Study Arms (2)
ACE
Patients treated for hypertension with ACEs without CVD
Candesartan
Patients treated for hypertension with candesartan without CVD
Eligibility Criteria
Patient treated with ACE or candesartan in the period 1999 - 2007.
You may qualify if:
- 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.
You may not qualify if:
- No history of cardiovascular disease.
- Ongoing malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (56)
Research Site
Avesta, Sweden
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Älvdalen, Sweden
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Ängelholm, Sweden
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Åkersberga, Sweden
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Bengtsfors, Sweden
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Borlänge, Sweden
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Falun, Sweden
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Farsta, Sweden
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Fritsla, Sweden
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Gagnef, Sweden
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Gävle, Sweden
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Gothenburg, Sweden
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Grängesberg, Sweden
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Grycksbo, Sweden
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Hallstahammar, Sweden
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Hägersten, Sweden
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Hässelby, Sweden
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Hedemora, Sweden
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Helsingborg, Sweden
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Henån, Sweden
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Höllviken, Sweden
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Jarfalla, Sweden
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Kil, Sweden
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Kolbäck, Sweden
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Kolsva, Sweden
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Köping, Sweden
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Leksand, Sweden
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Lidköping, Sweden
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Likenäs, Sweden
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Limhamn, Sweden
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Ludvika, Sweden
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Malmo, Sweden
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Malung, Sweden
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Mora, Sweden
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Munka-Ljungby, Sweden
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Norberg, Sweden
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Sala, Sweden
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Säter, Sweden
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Skanör, Sweden
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Skepplanda, Sweden
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Skinnskatteberg, Sweden
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Skogås, Sweden
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Skoghall, Sweden
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Skövde, Sweden
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Skultuna, Sweden
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Smedjebacken, Sweden
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Stockholm, Sweden
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Stora Höga, Sweden
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Sunnansjö, Sweden
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Sunne, Sweden
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Svärdsjö, Sweden
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Trollhättan, Sweden
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Upplands Vasby, Sweden
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Uppsala, Sweden
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Vansbro, Sweden
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Västerås, Sweden
Related Publications (1)
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.
PMID: 25211055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Niklas Lindarck
AstraZeneca Nordic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2010
First Posted
June 29, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 27, 2011
Record last verified: 2011-09