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

AstraZeneca1 site in 1 country50,000 target enrollmentJune 2010

ConditionsHypertension Cardiovascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: AstraZeneca
Enrollment: 50000
Locations: 1
Primary Endpoint: Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

November 2010

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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
•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

Outcomes

Primary Outcomes

Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension

Time Frame: 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

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)