Atacand (Candesartan) Real Life Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00620178

Purpose

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)

Condition	Intervention
Hypertension	Drug: Candesartan Cilexetil Drug: Losartan

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Candesartan cilexetil CV 11974 Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Blood pressure recordings will be followed for the available observation periods with detail to when and to what degree levels less than 140/90 are reached. [ Time Frame: 1999 - 2007 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	14000
Study Start Date:	February 2008
Study Completion Date:	August 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Candesartan	Drug: Candesartan Cilexetil oral once daily dose
2 Losartan	Drug: Losartan once daily oral dose

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Recorded blood pressure prior to therapy of > 140 and/or 90 mmHg
Diagnosed as hypertensive within 15 months

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620178

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Jan Stålhammar, MD

Eriksbergs vårdcentral

More Information

Responsible Party:	AstraZeneca ( Anders Ljunggren, MD )
Study ID Numbers:	NIS-CSE-ATA-2008/1
Study First Received:	February 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00620178
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

candesartan
losartan
blood pressure
cardiovascular disease
health care consumption

Study placed in the following topic categories:

Candesartan cilexetil
Losartan
Candesartan

Vascular Diseases
Angiotensin II
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009