Atacand (Candesartan) Real Life Study

NCT00620178 | Completed

• 1 other identifier: NIS-CSE-ATA-2008/1
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Hypertension

Keywords

candesartan; losartan; blood pressure; cardiovascular disease; health care consumption

Outcome Measures

Primary Outcomes (1)

• The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).

  1999 - 2007

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

1

Candesartan

Drug: Candesartan Cilexetil

2

Losartan

Drug: Losartan

Interventions

Candesartan Cilexetil DRUG

oral once daily dose

Also known as: ATACAND

1

Losartan DRUG

once daily oral dose

Also known as: COZAAR

2

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

candesartan cilexetil; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Jan Stålhammar, MD

  Eriksbergs vårdcentral

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 2, 2010

Record last verified: 2010-12

Locations

SE (1)