DyslipidemiasRACHELNCT00931320
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients
An observational study of Dyslipidemias, run by AstraZeneca.
Trial summary
An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Sep 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 at least made 1 visit to the outpatient clinic within previous 6 months .
Who may be able to join
- Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia
- Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months
- Subjects who have records of both LDL-C and HDL-C before \& after statin treatment (at least four weeks after statin taking)
Who cannot join
- Subjects who are unwilling or unable to provide their examination and lab result of medical chart.
About this study
An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.
- Conditions
- Dyslipidemias
- Keywords
- Ratio improvement, LDL-C, HDL-C, Ratio of Low Density Lipoprotein Cholesterol to High Density Lipoprotein Cholesterol Improvement, High Density Lipoprotein Cholesterol
- Medical subject headings
- Dyslipidemias
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 |
|---|---|---|
| 3000 patients | Who have at least made 1 visit to the outpatient clinic within previous 6 months . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment)
Measured: After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.
Secondary outcomes (1)
Evaluate difference of LDL/HDL ratio among different statins & dosages (between baseline & after treatment)
Measured: After Treatment : at least 4 weeks before statin taking / Baseline : no limitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyunah Caroline Choi, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931320
- Sponsor's protocol ID
- NIS-CKR-DUM-2009/3
- Acronym
- RACHEL
- Status last verified
- Oct 2009
- First submitted
- 30 Jun 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients
- ClinicalTrials.gov ID
- NCT00931320
- Acronym / sponsor ID
- RACHEL / NIS-CKR-DUM-2009/3
- Conditions
- Dyslipidemias
- Keywords
- Ratio improvement, LDL-C, HDL-C, Ratio of Low Density Lipoprotein Cholesterol to High Density Lipoprotein Cholesterol Improvement, High Density Lipoprotein Cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Jul 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 ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3000 patients | – | –Who have at least made 1 visit to the outpatient clinic within previous 6 months . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Who have at least made 1 visit to the outpatient clinic within previous 6 months .
Key inclusion criteria (3 listed)
- Subjects who are taking lipid-lowering medication after diagnosed as dyslipidaemia
- Subjects who have at least made 1 visit to the outpatient clinic within previous 6 months
- Subjects who have records of both LDL-C and HDL-C before \& after statin treatment (at least four weeks after statin taking)
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
Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment)
Time frame: After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.
1 secondary outcome
Evaluate difference of LDL/HDL ratio among different statins & dosages (between baseline & after treatment)
Time frame: After Treatment : at least 4 weeks before statin taking / Baseline : no limitation.
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 27 Oct 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.
Hyunah Caroline Choi study director
AstraZeneca Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by AstraZeneca.
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 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate current LDL/HDL ratio in Korean patients (between baseline & after treatment) (time frame: After Treatment : at least 4 weeks before statin taking /Baseline : no limitation.). 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 27 Oct 2009.