Atacand (Candesartan) Real Life Study

This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret),...

Date First Received: February 8, 2008

Last Updated: February 23, 2009

Verified by: AstraZeneca, February 2009

Clinical Trial Phase: N/A | Start Date: February 2008

Overall Status: Completed

Estimated Enrollment: 14000

Brief Summary

Official Title: “A REtrospective Study on the Effects of cAndesartan vs. Losartan on Blood Pressure, Health Care Consumption and cardiovascuLar Events In a "Real-liFe" GP sEtting in Sweden”

Condition Keyword(s):

This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart Intensive Care Admission (RIKS-HIA)

Study Type: Observational

Study Design: Cohort, Retrospective

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

  • Drug: Candesartan Cilexetil
    • oral once daily dose
  • Drug: Losartan
    • once daily oral dose

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • Candesartan
  • : 2
    • Losartan

Outcome Measures for this Clinical Trial

Primary Measures

  • The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).
    • Time Frame: 1999 - 2007
      Safety Issue?: No

Secondary Measures

  • Cardiovascular disease states and procedures in the background and over the entire observation period will be identified by use of ICD-9 and ICD-10 coding for diseases of the cardiovascular system. Specifically are death, acute cardiovascular events, new
    • Time Frame: 1999 - 2007
      Safety Issue?: No
  • Health care consumption will be assessed as contacts with health care providers, in-hospital time periods for cardiovascular disease states with associated therapeutic procedures, and times spent within various levels of care (e.g. ICU and general ward).
    • Time Frame: 1999 - 2007
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Recorded blood pressure prior to therapy of > 140 and/or 90 mmHg
  • Diagnosed as hypertensive within 15 months
  • First prescription of Cozaar or Atacand between 1 January 1999 and 31 December 2007, inclusive

Exclusion Criteria:

  • Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 -
  • C09 inclusive

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 17 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Jan Stålhammar, MD Principal Investigator Eriksbergs vårdcentral  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620178

Study ID Number: NIS-CSE-ATA-2008/1

ClinicalTrials.gov Identifier: NCT00620178

Health Authority: Sweden: Regional Ethical Review Board

Clinical Trials Authorship and Review

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