Clinical trial NCT01152567: Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension
Official title: Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Cardiovascular Disease
Keywords: Hypertension
ACE
ARB
real life data
CVD
cost effectiveness
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 50000
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated with ACE or candesartan in the period 1999 - 2007.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* No history of cardiovascular disease.
* Ongoing malignancy

Primary outcomes:
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.
Secondary outcomes:
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
Other outcomes:
Locations:
city: Akersberga
country: Sweden
facility: Research Site
city: Alvdalen
country: Sweden
facility: Research Site
city: Angelholm
country: Sweden
facility: Research Site
city: Avesta
country: Sweden
facility: Research Site
city: Bengtsfors
country: Sweden
facility: Research Site
city: Borlange
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Farsta
country: Sweden
facility: Research Site
city: Fritsla
country: Sweden
facility: Research Site
city: Gagnef
country: Sweden
facility: Research Site
city: Gavle
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Grangesberg
country: Sweden
facility: Research Site
city: Grycksbo
country: Sweden
facility: Research Site
city: Hagersten
country: Sweden
facility: Research Site
city: Hallstahammar
country: Sweden
facility: Research Site
city: Hasselby
country: Sweden
facility: Research Site
city: Hedemora
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: HenAn
country: Sweden
facility: Research Site
city: Hollviken
country: Sweden
facility: Research Site
city: Jarfalla
country: Sweden
facility: Research Site
city: Kil
country: Sweden
facility: Research Site
city: Kolback
country: Sweden
facility: Research Site
city: Kolsva
country: Sweden
facility: Research Site
city: Koping
country: Sweden
facility: Research Site
city: Leksand
country: Sweden
facility: Research Site
city: Lidkoping
country: Sweden
facility: Research Site
city: Likenas
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Ludvika
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Malung
country: Sweden
facility: Research Site
city: Mora
country: Sweden
facility: Research Site
city: Munka-Ljungby
country: Sweden
facility: Research Site
city: Norberg
country: Sweden
facility: Research Site
city: Sala
country: Sweden
facility: Research Site
city: Sater
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Skepplanda
country: Sweden
facility: Research Site
city: Skinnskatteberg
country: Sweden
facility: Research Site
city: Skogas
country: Sweden
facility: Research Site
city: Skoghall
country: Sweden
facility: Research Site
city: Skovde
country: Sweden
facility: Research Site
city: Skultuna
country: Sweden
facility: Research Site
city: Smedjebacken
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stora Hoga
country: Sweden
facility: Research Site
city: Sunnansjo
country: Sweden
facility: Research Site
city: Sunne
country: Sweden
facility: Research Site
city: Svardsjo
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Upplands Vasby
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Vansbro
country: Sweden
facility: Research Site
city: VasterAs
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Nordic
name: Niklas Lindarck
role: STUDY_DIRECTOR
References:
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.