HypertensionSAPIENCENCT00785057
Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke
An observational study of Hypertension, run by AstraZeneca at 8 sites in South Korea.
Trial summary
This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 1,000 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Nov 2008to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertension outpatients coming to the Neurology Department
Who may be able to join
- Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication
Who cannot join
- Secondary hypertension patients
- Patients not receiving hypertension medication
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Research Site
Busan
Research Site
Deagu
Research Site
Deajeon
Research Site
Goyang-si, Gyeonggi-do
Research Site
Kwangju
Research Site
Seoul
Research Site
Sungnam, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
About this study
Official title: A Retrospective, Multi Centre, Non-interventional, Observational Study to Compare Treatment Pattern and Factors That Affect BP Control in Patients With and Without Stroke
This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.
- Conditions
- Hypertension
- Keywords
- Hypertension, Stroke, Neurology, JNC7, 2007 ESH-ESC guidelines, survey
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Hypertension patients with history of stroke | |
| 2 | Hypertension patients without history of stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure, History of stroke, Antihypertensive medication
Measured: After collecting all Patient Record Form.
Secondary outcomes (1)
Blood pressure, History of stroke, antihypertensive medication, Classification of stroke, Risk factors, Concomitant medication, etc.
Measured: After collecting all Patient Record Form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joonwoo Bahn, Study director, Astrazenca Korea medical dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785057
- Sponsor's protocol ID
- NIS-CKR-DUM-2008/4
- Acronym
- SAPIENCE
- Status last verified
- Dec 2010
- First submitted
- 4 Nov 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi Centre, Non-interventional, Observational Study to Compare Treatment Pattern and Factors That Affect BP Control in Patients With and Without Stroke
- ClinicalTrials.gov ID
- NCT00785057
- Acronym / sponsor ID
- SAPIENCE / NIS-CKR-DUM-2008/4
- Conditions
- Hypertension
- Keywords
- Hypertension, Stroke, Neurology, JNC7, 2007 ESH-ESC guidelines, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Nov 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 will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Hypertension patients with history of stroke |
| 2 | – | –Hypertension patients without history of stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertension outpatients coming to the Neurology Department
Key inclusion criteria (1 listed)
- Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication
Key exclusion criteria (2 listed)
- Secondary hypertension patients
- Patients not receiving hypertension medication
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
Blood pressure, History of stroke, Antihypertensive medication
Time frame: After collecting all Patient Record Form.
1 secondary outcome
Blood pressure, History of stroke, antihypertensive medication, Classification of stroke, Risk factors, Concomitant medication, etc.
Time frame: After collecting all Patient Record Form.
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 3 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.
Joonwoo Bahn study director
Astrazenca Korea medical dept.
8 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, run by AstraZeneca at 8 sites in South Korea.
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 3 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 8 sites in South Korea. 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?
Blood pressure, History of stroke, Antihypertensive medication (time frame: After collecting all Patient Record Form.). 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 3 Dec 2010.