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: Losartan Losartan potassium CV 11974 Candesartan cilexetil

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:

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

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

No publications provided

Responsible Party:	AstraZeneca ( Anders Ljunggren, MD )
Study ID Numbers:	NIS-CSE-ATA-2008/1
Study First Received:	February 8, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00620178 History of Changes
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:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Losartan
Candesartan
Vascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Angiotensin II
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Candesartan cilexetil

Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009