Low Density Lipoprotein Cholesterol Goal AchievementDARTNCT00925717
of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).
An observational study of Low Density Lipoprotein Cholesterol Goal Achievement, run by AstraZeneca at 22 sites in South Korea.
Trial summary
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Density Lipoprotein Cholesterol Goal Achievement
- How many people
- 4,045 participants
- Where
- 22 sitesSouth Korea
- Study dates
- May 2009to Oct 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: Who have records of clinic visit with endocrine internal medicines of nationwide secondary/tertiary hospitals within the last six months.
Who may be able to join
- Subjects who was diagnosed as diabetes
- Subjects who was diagnosed as dyslipidaemia or takes lipid lowering medication
- Clinic visit in the past 6 months more than once
Who cannot join
- Subjects who are unwilling or unable to provide their examination and lab result of medical chart.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
South Korea22 sites
Research Site
Ansan-si, Gyeonggi-do
Research Site
Anyang-si, Gyeonggi-do
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Busan
Research Site
Cheonan-si, Chungchungnam-do
Research Site
Cheonju-si
Research Site
Chuncheon, Gangwon-do
Research Site
Daegu
Research Site
Daejeon
Research Site
Gangneung, Gangwon-do
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gwangju-si, Jeollanam-do
Research Site
Incheon
Research Site
Jeonju, Jeonllabuk-do
Research Site
Jeonju
Research Site
Kwangju-si
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Suncheon, Jeollanam-do
Research Site
Suwon, Gyeonggi-do
Research Site
Uijeongbu-si, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
About this study
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.
- Keywords
- ADA recommendation
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 |
|---|---|---|
| 2500 patients | Who have records of clinic visit with endocrine internal medicines of nationwide secondary/tertiary hospitals within the last six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate LDL-C goal achievement rate according to ADA recommendation
Measured: Within the last 6 months from the date of data entry.
Secondary outcomes (1)
Investigate reduction of 10-year risk for CHD by using UKPDS risk engine
Measured: Within the last 6 months from the date of data entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startMay 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Density Lipoprotein Cholesterol Goal AchievementStudies 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
- 4,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MoonGyu Lee, Ph.D., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925717
- Sponsor's protocol ID
- NIS-CKR-DUM-2009/1
- Acronym
- DART
- Status last verified
- Jan 2010
- First submitted
- 19 Jun 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).
- ClinicalTrials.gov ID
- NCT00925717
- Acronym / sponsor ID
- DART / NIS-CKR-DUM-2009/1
- Keywords
- ADA recommendation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,045 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Jun 2009 (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.
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2500 patients | – | –Who have records of clinic visit with endocrine internal medicines of nationwide secondary/tertiary hospitals within the last six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Who have records of clinic visit with endocrine internal medicines of nationwide secondary/tertiary hospitals within the last six months.
Key inclusion criteria (3 listed)
- Subjects who was diagnosed as diabetes
- Subjects who was diagnosed as dyslipidaemia or takes lipid lowering medication
- Clinic visit in the past 6 months more than once
Key exclusion criteria (1 listed)
- Subjects who are unwilling or unable to provide their examination and lab result of medical chart.
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 LDL-C goal achievement rate according to ADA recommendation
Time frame: Within the last 6 months from the date of data entry.
1 secondary outcome
Investigate reduction of 10-year risk for CHD by using UKPDS risk engine
Time frame: Within the last 6 months from the date of data entry.
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 26 Jan 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.
MoonGyu Lee, Ph.D. study director
Samsung Medical Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Density Lipoprotein Cholesterol Goal Achievement, run by AstraZeneca at 22 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 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 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Investigate LDL-C goal achievement rate according to ADA recommendation (time frame: Within the last 6 months from the date of data entry.). 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 26 Jan 2010.