HypertensionCRYSTAL-CONCT00771069
Hypertensive Treatment Pattern Survey for Type II Diabetes Mellitus Patients With Complication and Hypertension
An observational study of Hypertension, run by AstraZeneca at 13 sites in South Korea.
Trial summary
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 2,000 participants
- Where
- 13 sitesSouth Korea
- Study dates
- Nov 2008to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type II Diabetes Mellitus patients with Complication and Hypertension
Who may be able to join
- After diagnosed type II DM, patients received treatment for a least 3 years
- Type II DM patients with hypertension and its complication.
- Visited out-patients to care center after 1 Jan. 2008
Who cannot join
- Secondary hypertension patients
- Patients not receiving hypertension medication
- Patients stopping BP medication, by physician's order
- Patients currently enrolled in other clinical studies
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan
Research Site
Deagu
Research Site
Deajeon
Research Site
Goyang-si, Gyeonggi-do
Research Site
Guri-si, Gyeonggi-do
Research Site
Incheon
Research Site
Jeonju, Keollabuk
Research Site
Kwangju
Research Site
Seoul
Research Site
Sungnam, Gyeonggi-do
Research Site
Suwon, 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 Type II Diabetes Mellitus Patients With DM Related Complication and Hypertension.
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.
- Conditions
- Hypertension
- Keywords
- Hypertension, Type II DM, DM related complication, 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 | Type II Diabetes Mellitus patients with Complication and Hypertension |
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 (3)
Attainment to the target blood pressure will be investigated according to DM related complications.
Measured: After collecting all Patient Record Form.
Change in the DBP/SBP value will be investigated according to the DM Complication
Measured: After collecting all Patient Record Form.
Treatment pattern and factors that affect BP control
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 posted10 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joonwoo Bahn, Study director, Astrazenca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771069
- Sponsor's protocol ID
- NIS-CKR-DUM-2008/3
- Acronym
- CRYSTAL-CO
- Status last verified
- Dec 2010
- First submitted
- 9 Oct 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 Investigate Treatment Pattern of Blood Pressure in the Type II Diabetes Mellitus Patients With DM Related Complication and Hypertension.
- ClinicalTrials.gov ID
- NCT00771069
- Acronym / sponsor ID
- CRYSTAL-CO / NIS-CKR-DUM-2008/3
- Conditions
- Hypertension
- Keywords
- Hypertension, Type II DM, DM related complication, JNC7, 2007 ESH-ESC guidelines, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Oct 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 to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Type II Diabetes Mellitus patients with Complication and Hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type II Diabetes Mellitus patients with Complication and Hypertension
Key inclusion criteria (3 listed)
- After diagnosed type II DM, patients received treatment for a least 3 years
- Type II DM patients with hypertension and its complication.
- Visited out-patients to care center after 1 Jan. 2008
Key exclusion criteria (4 listed)
- Secondary hypertension patients
- Patients not receiving hypertension medication
- Patients stopping BP medication, by physician's order
- Patients currently enrolled in other clinical studies
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.
3 secondary outcomes
Attainment to the target blood pressure will be investigated according to DM related complications.
Time frame: After collecting all Patient Record Form.
Change in the DBP/SBP value will be investigated according to the DM Complication
Time frame: After collecting all Patient Record Form.
Treatment pattern and factors that affect BP control
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
13 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 13 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 3 inclusion and 4 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 13 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 3 Dec 2010.