HypertensionSAPPHIRENCT00681707
Retrospective Treatment Pattern Survey for the Patients With Hypertension and Stroke
An observational study of Hypertension, run by AstraZeneca at 8 sites in South Korea.
Trial summary
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors that affect BP control by examining retrospective medical records of hypertension patients recovering from stroke, among outpatients coming to the Neurology Department in 10 university hospitals nationwide. 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
- May 2008to Jul 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: Patient with history of stroke, receiving hypertension medication during at least 1 year.
Who may be able to join
- Patients had been hospitalized as a acute stroke in 2006
- Patient with history of stroke receiving hypertension medication during at least 1 year.
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 Investigate Treatment Pattern of Blood Pressure in the Post Stroke Patients With Hypertension.
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors that affect BP control by examining retrospective medical records of hypertension patients recovering from stroke, among outpatients coming to the Neurology Department in 10 university hospitals nationwide.
- Conditions
- Hypertension
- Keywords
- Hypertension, Post stroke, JNC7, 2007 ESH-ESC guidelines, survey
- Medical subject headings
- Hypertension
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 recovering from stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment rate to the target blood pressure
Measured: After collecting all Patient Record Form.
Secondary outcomes (2)
Dropout rate will be estimated during the follow-up period after the hypertension treatment. Attainment to the target blood pressure will be investigated according to concomitant diseases.
Measured: After collecting all Patient Record Form.
Change in DBP/SBP value during the follow-up period will be addressed. Change in the DBP/SBP value will be investigated according to the risk factors and concurrent disease.
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 posted21 May 2008 (estimated)
- Study startMay 2008
- Study completionJul 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
- Joon Woo Bahn, Study director, Astrazenca Korea medical dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681707
- Sponsor's protocol ID
- NIS-CKR-DUM-2008/1
- Acronym
- SAPPHIRE
- Status last verified
- Jul 2009
- First submitted
- 19 May 2008
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi Centre, Non-Interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Post Stroke Patients With Hypertension.
- ClinicalTrials.gov ID
- NCT00681707
- Acronym / sponsor ID
- SAPPHIRE / NIS-CKR-DUM-2008/1
- Conditions
- Hypertension
- Keywords
- Hypertension, Post stroke, 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
- May 2008
- Study completion
- Jul 2008 (actual)
- First posted
- 21 May 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 address the treatment rate and control rate of hypertension, treatment pattern and factors that affect BP control by examining retrospective medical records of hypertension patients recovering from stroke, among outpatients coming to the Neurology Department in 10 university hospitals nationwide.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Hypertension patients recovering from stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with history of stroke, receiving hypertension medication during at least 1 year.
Key inclusion criteria (2 listed)
- Patients had been hospitalized as a acute stroke in 2006
- Patient with history of stroke receiving hypertension medication during at least 1 year.
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
Attainment rate to the target blood pressure
Time frame: After collecting all Patient Record Form.
2 secondary outcomes
Dropout rate will be estimated during the follow-up period after the hypertension treatment. Attainment to the target blood pressure will be investigated according to concomitant diseases.
Time frame: After collecting all Patient Record Form.
Change in DBP/SBP value during the follow-up period will be addressed. Change in the DBP/SBP value will be investigated according to the risk factors and concurrent disease.
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 9 Jul 2009.
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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.
Joon Woo 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 2 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 9 Jul 2009. 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?
Attainment rate to the target blood pressure (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 9 Jul 2009.