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Completed

NCT Number: NCT01152567

Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus 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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Avesta, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ARBACE

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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