Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension (ARBACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01152567
First received: June 18, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

The planned Study will be a retrospective study on the effect of ACE's vs. candesartan on cardiovascular events and on health economic effects in a "real life" setting in Sweden.


Condition
Hypertension
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension [ Time Frame: Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension [ Time Frame: Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs. ] [ Designated as safety issue: No ]
  • To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan [ Time Frame: Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs. ] [ Designated as safety issue: No ]
  • Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness [ Time Frame: Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year ] [ Designated as safety issue: No ]

Enrollment: 50000
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
ACE
Patients treated for hypertension with ACEs without CVD
Candesartan
Patients treated for hypertension with candesartan without CVD

  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

Patient treated with ACE or candesartan in the period 1999 - 2007.

Criteria

Inclusion Criteria:

  • all patients found in electronic patient journals at the participating centres, who were prescribed either ACEis (ATC-C09A-B) or ARBs (C09C-D) for hypertension from 1 January 1999 - 31 December 2007. The first date of such a prescription starts the observation time and is called the index prescription.

Exclusion Criteria:

  • No history of cardiovascular disease.
  • Ongoing malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152567

  Show 56 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Niklas Lindarck AstraZeneca Nordic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01152567     History of Changes
Other Study ID Numbers: NIS-CSE-ATA-2010/1
Study First Received: June 18, 2010
Last Updated: September 26, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Hypertension
ACE
ARB
real life data
CVD
cost effectiveness

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Candesartan
Candesartan cilexetil
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014