DyslipidemiasNCT05614765
Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment
An observational study of Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Statin+Ezetimibe compound
- Type of treatment
- Pill or oral medicine
- How many people
- 18,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In order to assume the amount of LDL-C change at 24 weeks compared to the base value, the clinical trial results of the test subjects with similar underlying diseases that can be currently referred to were used.
Who may be able to join
- Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)
- Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex
- A person who can understand the information provided to him or her and voluntarily sign a written consent form
Who cannot join
- Patients who overreact to the main ingredients or components of the drug in the study
- Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause
- Patients with muscle disease.
- Pregnant women or pregnant women and nursing mothers
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
- A person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration
- In addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Data Observational Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient in the Medical Situation by Classification of Medical Institutions in KOREA
This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.
Read the detailed description
All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.
Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).
To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
- Conditions
- Dyslipidemias
- Being tested
- Statin+Ezetimibe compound
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin+Ezetimibe compoundDrug
Crezet Tablet, Litorvazet Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | statin+ezetimibe compound Receives: Drug: Statin+Ezetimibe compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C)
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) at 24 weeks compared to baseline
Measured: 24 weeks
Secondary outcomes (5)
LDL-C change rate and amount
LDL-C change rate and amount at 12 weeks compared to baseline
Measured: 12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 12 weeks compared to baseline
Measured: 12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 24 weeks compared to baseline
Measured: 24 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 12 weeks compared to baseline
Measured: 12 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 24 weeks compared to baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start8 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (estimated)
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 Daewoong Pharmaceutical Co. LTD.The 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JinWon Kim, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614765
- Sponsor's protocol ID
- DWLC_RWE02
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not Yet decided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Data Observational Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient in the Medical Situation by Classification of Medical Institutions in KOREA
- ClinicalTrials.gov ID
- NCT05614765
- Acronym / sponsor ID
- DWLC_RWE02
- Conditions
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Nov 2022 (actual)
- 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 is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.
Detailed description
All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.
Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).
To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Statin+Ezetimibe compoundstatin+ezetimibe compound |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In order to assume the amount of LDL-C change at 24 weeks compared to the base value, the clinical trial results of the test subjects with similar underlying diseases that can be currently referred to were used.
Key inclusion criteria (3 listed)
- Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)
- Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex
- A person who can understand the information provided to him or her and voluntarily sign a written consent form
Key exclusion criteria (7 listed)
- Patients who overreact to the main ingredients or components of the drug in the study
- Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause
- Patients with muscle disease.
- Pregnant women or pregnant women and nursing mothers
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin+Ezetimibe compoundCrezet Tablet, Litorvazet Tablet | Drug | Treatment group |
Primary outcome
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C)
Time frame: 24 weeks
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) at 24 weeks compared to baseline
5 secondary outcomes
LDL-C change rate and amount
Time frame: 12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)
Time frame: 12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)
Time frame: 24 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)
Time frame: 12 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided. Not Yet decided
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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.
JinWon Kim principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site 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 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) (time frame: 24 weeks). 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 24 Aug 2025.