Atacand (Candesartan) Real Life Study

Hypertension Clinical Trial

— Real Life  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620178
• Other study ID #: NIS-CSE-ATA-2008/1
• Status: Completed
• Phase: N/A
• First received: February 8, 2008
• Last updated: December 1, 2010
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14000
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).		1999 - 2007	No
Secondary	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		1999 - 2007	No
Secondary	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).		1999 - 2007	No