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

September 26, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • 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, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient treated with ACE or candesartan in the period 1999 - 2007.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ACE
Patients treated for hypertension with ACEs without CVD
Candesartan
Patients treated for hypertension with candesartan without CVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi 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.
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 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.
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
Time Frame: Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year
Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Niklas Lindarck, AstraZeneca Nordic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

June 18, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CSE-ATA-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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