Atacand (Candesartan) Real Life Study (Real Life)

December 1, 2010 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

14000

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
      • Uppsala, 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

Eligible subjects are all patients found in EPS systems at the participating centres, who were prescribed candesartan (ATC-C09CA06) or losartan (C09CA01) for hypertension from 1 January 1999 - 31 December 2004 inclusive. The first found prescription is designated as index.

Description

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

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
Intervention / Treatment
1
Candesartan
Drug: Candesartan Cilexetil
oral once daily dose
Other Names:
  • ATACAND
2
Losartan
Drug: Losartan
once daily oral dose
Other Names:
  • COZAAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).
Time Frame: 1999 - 2007
1999 - 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1999 - 2007
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
1999 - 2007

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Jan Stålhammar, MD, Eriksbergs vårdcentral

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

March 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CSE-ATA-2008/1

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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