Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Hypertension Clinical Trial

— ARBACE  

Official title:

Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152567
• Other study ID #: NIS-CSE-ATA-2010/1
• Status: Completed
• Phase: N/A
• First received: June 18, 2010
• Last updated: September 26, 2011
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Locations

Country	Name	City	State
Sweden	Research Site	Akersberga
Sweden	Research Site	Alvdalen
Sweden	Research Site	Angelholm
Sweden	Research Site	Avesta
Sweden	Research Site	Bengtsfors
Sweden	Research Site	Borlange
Sweden	Research Site	Falun
Sweden	Research Site	Farsta
Sweden	Research Site	Fritsla
Sweden	Research Site	Gagnef
Sweden	Research Site	Gavle
Sweden	Research Site	Goteborg
Sweden	Research Site	Grangesberg
Sweden	Research Site	Grycksbo
Sweden	Research Site	Hagersten
Sweden	Research Site	Hallstahammar
Sweden	Research Site	Hasselby
Sweden	Research Site	Hedemora
Sweden	Research Site	Helsingborg
Sweden	Research Site	HenAn
Sweden	Research Site	Hollviken
Sweden	Research Site	Jarfalla
Sweden	Research Site	Kil
Sweden	Research Site	Kolback
Sweden	Research Site	Kolsva
Sweden	Research Site	Koping
Sweden	Research Site	Leksand
Sweden	Research Site	Lidkoping
Sweden	Research Site	Likenas
Sweden	Research Site	Limhamn
Sweden	Research Site	Ludvika
Sweden	Research Site	Malmo
Sweden	Research Site	Malung
Sweden	Research Site	Mora
Sweden	Research Site	Munka-Ljungby
Sweden	Research Site	Norberg
Sweden	Research Site	Sala
Sweden	Research Site	Sater
Sweden	Research Site	Skanor
Sweden	Research Site	Skepplanda
Sweden	Research Site	Skinnskatteberg
Sweden	Research Site	Skogas
Sweden	Research Site	Skoghall
Sweden	Research Site	Skovde
Sweden	Research Site	Skultuna
Sweden	Research Site	Smedjebacken
Sweden	Research Site	Stockholm
Sweden	Research Site	Stora Hoga
Sweden	Research Site	Sunnansjo
Sweden	Research Site	Sunne
Sweden	Research Site	Svardsjo
Sweden	Research Site	Trollhattan
Sweden	Research Site	Upplands Vasby
Sweden	Research Site	Uppsala
Sweden	Research Site	Vansbro
Sweden	Research Site	VasterAs

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No