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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014