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

An observational study of Hypertension and Cardiovascular Disease, run by AstraZeneca at 56 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Hypertension, Cardiovascular Disease
How many people: 50,000 participants
Where: 56 sitesSweden
Study dates: Jun 2010to Nov 2010
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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.

Who cannot join

No history of cardiovascular disease.
Ongoing malignancy

Trial locations and contacts

56 sites in 1 country.

City, postcode or hospital

56 sites in 1 country

Sweden56 sites

Research Site
Åkersberga
Research Site
Älvdalen
Research Site
Ängelholm
Research Site
Avesta
Research Site
Bengtsfors
Research Site
Borlänge
Research Site
Falun
Research Site
Färsta
Research Site
Fritsla
Research Site
Gagnef
Research Site
Gävle
Research Site
Gothenburg
Research Site
Grängesberg
Research Site
Grycksbo
Research Site
Hägersten
Research Site
Hallstahammar
Research Site
Hässelby
Research Site
Hedemora
Research Site
Helsingborg
Research Site
Henån
Research Site
Höllviken
Research Site
Jarfalla
Research Site
Kil
Research Site
Kolbäck
Research Site
Kolsva
Research Site
Köping
Research Site
Leksand
Research Site
Lidköping
Research Site
Likenäs
Research Site
Limhamn
Research Site
Ludvika
Research Site
Malmö
Research Site
Malung
Research Site
Mora
Research Site
Munka-Ljungby
Research Site
Norberg
Research Site
Sala
Research Site
Säter
Research Site
Skanör
Research Site
Skepplanda
Research Site
Skinnskatteberg
Research Site
Skogås
Research Site
Skoghall
Research Site
Skövde
Research Site
Skultuna
Research Site
Smedjebacken
Research Site
Stockholm
Research Site
Stora Höga
Research Site
Sunnansjö
Research Site
Sunne
Research Site
Svärdsjö
Research Site
Trollhättan
Research Site
Upplands Vasby
Research Site
Uppsala
Research Site
Vansbro
Research Site
Västerås

Other trials in Sweden

About this study

Official title: Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

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.

Conditions: Hypertension, Cardiovascular Disease
Keywords: Hypertension, ACE, ARB, real life data, CVD, cost effectiveness
Medical subject headings: Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01152567
Study group	Role	What they receive
ACE		Patients treated for hypertension with ACEs without CVD
Candesartan		Patients treated for hypertension with candesartan without CVD

What is being measured

The primary outcome is the main question the study is designed to answer.

Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension
Measured: 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.

Secondary outcomes (3)

To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension
Measured: 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.
To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan
Measured: 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.
Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness
Measured: Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2010

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 50,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152567
Sponsor's protocol ID: NIS-CSE-ATA-2010/1
Acronym: ARBACE
Status last verified: Sep 2011
First submitted: 18 Jun 2010
Last updated: 27 Sep 2011
Results posted: No
Data monitoring committee: No

Publications

Hasvold LP, Bodegard J, Thuresson M, Stalhammar J, Hammar N, Sundstrom J, Russell D, Kjeldsen SE. Diabetes and CVD risk during angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment in hypertension: a study of 15,990 patients. J Hum Hypertens. 2014 Nov;28(11):663-9. doi: 10.1038/jhh.2014.43. Epub 2014 Jun 26.
PubMed 25211055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension
ClinicalTrials.gov ID: NCT01152567
Acronym / sponsor ID: ARBACE / NIS-CSE-ATA-2010/1
Conditions: Hypertension, Cardiovascular Disease
Keywords: Hypertension, ACE, ARB, real life data, CVD, cost effectiveness
Study type: Observational
Recruitment status: Completed
Enrolment: 50,000 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ACE	–	–Patients treated for hypertension with ACEs without CVD
Candesartan	–	–Patients treated for hypertension with candesartan without CVD

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patient treated with ACE or candesartan in the period 1999 - 2007.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (2 listed)

No history of cardiovascular disease.
Ongoing malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

3 secondary outcomes

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.
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.
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Derived from this study: PubMed 25211055Hasvold LP, Bodegard J, Thuresson M, Stalhammar J, Hammar N, Sundstrom J, Russell D, Kjeldsen SE. Diabetes and CVD risk during angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment in hypertension: a study of 15,990 patients. J Hum Hypertens. 2014 Nov;28(11):663-9. doi: 10.1038/jhh.2014.43. Epub 2014 Jun 26.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Niklas Lindarck study director

AstraZeneca Nordic

56 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Cardiovascular Disease, run by AstraZeneca at 56 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.