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

Completed

• Conditions: Hypertension; Cardiovascular Disease

• Registration Number: NCT01152567
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 VasterAs, Sweden