HypertensionReal LifeNCT00620178
Atacand (Candesartan) Real Life Study
An observational study of Hypertension, run by AstraZeneca at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan Cilexetil and Losartan
- Type of treatment
- Pill or oral medicine
- How many people
- 14,000 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to Feb 2009
- 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: 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.
Who may be able to join
- 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
Who cannot join
- Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
- Conditions
- Hypertension
- Being tested
- Candesartan Cilexetil, Losartan
- Keywords
- candesartan, losartan, blood pressure, cardiovascular disease, health care consumption
- 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.
Candesartan CilexetilDrug
Also called ATACAND
oral once daily dose
LosartanDrug
Also called COZAAR
once daily oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Candesartan Receives: Drug: Candesartan Cilexetil | |
| 2 | Losartan Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).
Measured: 1999 - 2007
Secondary outcomes (2)
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
Measured: 1999 - 2007
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).
Measured: 1999 - 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Stålhammar, MD, Principal investigator, Eriksbergs vårdcentral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620178
- Sponsor's protocol ID
- NIS-CSE-ATA-2008/1
- Acronym
- Real Life
- Status last verified
- Dec 2010
- First submitted
- 8 Feb 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00620178
- Acronym / sponsor ID
- Real Life / NIS-CSE-ATA-2008/1
- Conditions
- Hypertension
- Keywords
- candesartan, losartan, blood pressure, cardiovascular disease, health care consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Feb 2008 (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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Candesartan CilexetilCandesartan |
| 2 | – | Drug: LosartanLosartan |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candesartan CilexetilAlso: ATACANDoral once daily dose | Drug | 1 |
| LosartanAlso: COZAARonce daily oral dose | Drug | 2 |
Primary outcome
The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).
Time frame: 1999 - 2007
2 secondary outcomes
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
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
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 2 Dec 2010.
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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.
Jan Stålhammar, MD principal investigator
Eriksbergs vårdcentral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by AstraZeneca at 1 site 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 3 inclusion and 1 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD). (time frame: 1999 - 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2010.