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DyslipidemiaNCT06866509

To Investigate Blood Lipid Changes and Safety After Litorvazet® Tablets in Dyslipidemia Patients

An observational study of Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the lipid-lowering effects and safety of administering Litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive Litorvazet tablets in a real-world clinical setting. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Dyslipidemia
What is being tested?
Litorvazet Tablet 10/10mg, Litorvazet Tablet10/20mg and Litorvazet Tablet 10/40mg
Type of treatment
Pill or oral medicine
How many people
3,000 participants
Where
1 siteSouth Korea
Study dates
28 Feb 2022to 28 Feb 2024
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: To estimate LDL-C changes at Week 24 in a dyslipidemia population on Ezetimibe/Atorvastatin, clinical trial data from participants with similar baseline conditions were used. The standard deviation (SD) of LDL-C changes ranged from 23.57 to 38.91 mg/dL in two studies, and a pooled SD was calculated. With a 20% dropout rate, 3,000 participants (2,400 evaluable) were included. Assuming an SD of 33 mg/dL for LDL-C changes, a two-sided 95% confidence interval with a 1.32 mg/dL margin of error was generated. Including the dropout rate, a total of 3,000 participants were selected.

Who may be able to join

  • Male and female adults aged 19 years or older at the time of the screening visit.
  • Patients with dyslipidemia who are scheduled to receive Litorvazet® tablets based on the investigator's (treating physician's) medical judgment and in accordance with the approved indications.
  • Individuals who have voluntarily provided written consent to participate in this study.

Who cannot join

  • Individuals who meet any contraindications for Litorvazet® tablets as specified in the product labeling:
  • Those with hypersensitivity to any components of this medication.
  • Patients with active liver disease or those with persistently elevated serum transaminase levels of unknown cause.
  • Patients with muscle disorders.
  • Pregnant women, women who may be pregnant, or breastfeeding mothers.
  • Women of childbearing potential who are not using appropriate contraceptive methods.
Show all 10Show fewer
  • Patients receiving glecaprevir and pibrentasvir.
  • Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Individuals with a history of receiving Litorvazett® tablets prior to participating in this study.
  • Individuals deemed unsuitable for participation in this observational study by the investigator (treating physician) for reasons beyond those listed above.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, 02841

Other trials in South Korea

About this study

Official title: A Prospective, Multicenter, Non-Interventional Observational Study to Investigate Changes in Blood Lipid Levels and Safety Following Administration of Litorvazet® Tablets in Patients With Dyslipidemia

This study aims to investigate the lipid-lowering effects and safety of administering Litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive Litorvazet tablets in a real-world clinical setting.

Read the detailed description

In a real-world clinical setting, Litorvazet® tablets will be administered to patients based on the investigator's medical judgment in accordance with the approved prescribing information (indications, dosage, and administration, precautions for use, etc.).

Participants for data collection in this study will be patients diagnosed with dyslipidemia as determined by the judgment of their attending physician.

All treatments, including drug administration and clinical laboratory tests conducted after the administration of Litorvazet® tablets, will be carried out based solely on the investigator's (attending physician's) medical judgment and will not be influenced by the patient's participation in the study. Information relevant to this observational study will be collected for up to 24 weeks.

Conditions
Dyslipidemia
Being tested
Litorvazet Tablet 10/10mg, Litorvazet Tablet10/20mg, Litorvazet Tablet 10/40mg
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Litorvazet Tablet 10/10mgDrug

    Ezetimibe 10 mg + Atorvastatin 10 mg

  • Litorvazet Tablet10/20mgDrug

    Ezetimibe 10 mg + Atorvastatin 20 mg

  • Litorvazet Tablet 10/40mgDrug

    Ezetimibe 10 mg + Atorvastatin 40 mg

Study groups in NCT06866509
Study groupRoleWhat they receive
Patients With DyslipidemiaPatients With Dyslipidemia
Receives: Drug: Litorvazet Tablet 10/10mg; Drug: Litorvazet Tablet10/20mg; Drug: Litorvazet Tablet 10/40mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LDL-C Levels Compared to Baseline

    Change in LDL-C Levels at Week 24 Compared to Baseline

    Measured: at Week 24

Secondary outcomes (56)

  1. Changes in LDL-C levels compared to baseline [excluding primary endpoints].

    Changes in LDL-C levels at Week 12 compared to baseline [excluding primary endpoints].

    Measured: at Week 12

  2. Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].

    Percentage changes (%) in LDL-C levels at Week 12 compared to baseline [excluding primary endpoints].

    Measured: at Week 12

  3. Changes in LDL-C levels compared to baseline [excluding primary endpoints].

    Changes in LDL-C levels at Week 24 compared to baseline [excluding primary endpoints].

    Measured: at Week 24

  4. Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].

    Percentage changes (%) in LDL-C levels at Week 24 compared to baseline [excluding primary endpoints].

    Measured: at Week 24

  5. Changes in HDL-C levels compared to baseline

    Changes in HDL-C levels at Week 12 compared to baseline.

    Measured: at Week 12

  6. Percentage changes (%) in HDL-C levels compared to baseline

    Percentage changes (%) in HDL-C levels at Week 12 compared to baseline.

    Measured: at Week 12

  7. Changes in HDL-C levels compared to baseline

    Changes in HDL-C levels at Week 24 compared to baseline.

    Measured: at Week 24

  8. Percentage changes (%) in HDL-C levels compared to baseline

    Percentage changes (%) in HDL-C levels at Week 24 compared to baseline.

    Measured: at Week 24

  9. Changes in Non-HDL-C levels compared to baseline

    Changes in Non-HDL-C levels at Week 12 compared to baseline

    Measured: at Week 12

  10. Percentage changes (%) in Non-HDL-C levels compared to baseline

    Percentage changes (%) in Non-HDL-C levels at Week 12 compared to baseline

    Measured: at Week 12

  11. Changes in Non-HDL-C levels compared to baseline

    Changes in Non-HDL-C levels at Week 24 compared to baseline

    Measured: at Week 24

  12. Percentage changes (%) in Non-HDL-C levels compared to baseline

    Percentage changes (%) in Non-HDL-C levels at Week 24 compared to baseline

    Measured: at Week 24

  13. Changes in TG levels compared to baseline

    Changes in TG levels at Week 12 compared to baseline.

    Measured: at Week 12

  14. Percentage changes (%) in TG levels compared to baseline

    Percentage changes (%) in TG levels at Week 12 compared to baseline.

    Measured: at Week 12

  15. Changes in TG levels compared to baseline

    Changes in TG levels at Week 24 compared to baseline

    Measured: at Week 24

  16. Percentage changes (%) in TG levels compared to baseline

    Percentage changes (%) in TG levels at Week 24 compared to baseline

    Measured: at Week 24

  17. Changes in TC levels compared to baseline

    Changes in TC levels at Week 12 compared to baseline

    Measured: at Week 12

  18. Percentage changes (%) in TC levels compared to baseline

    Percentage changes (%) in TC levels at Week 12 compared to baseline

    Measured: at Week 12

  19. Changes in TC levels compared to baseline

    Changes in TC levels at Week 24 compared to baseline

    Measured: at Week 24

  20. Percentage changes (%) in TC levels compared to baseline

    Percentage changes (%) in TC levels at Week 24 compared to baseline

    Measured: at Week 24

  21. Changes in ALT levels compared to baseline

    Changes in ALT levels at Week 12 compared to baseline

    Measured: at Week 12

  22. Changes in AST levels compared to baseline

    Changes in AST levels at Week 12 compared to baseline

    Measured: at Week 12

  23. Percentage changes (%) in ALT levels compared to baseline

    Percentage changes (%) in ALT levels at Week 12 compared to baseline

    Measured: at Week 12

  24. Percentage changes (%) in AST levels compared to baseline

    Percentage changes (%) in AST levels at Week 12 compared to baseline

    Measured: at Week 12

  25. Changes in ALT levels compared to baseline

    Changes in ALT levels at Week 24 compared to baseline

    Measured: at Week 24

  26. Changes in AST levels compared to baseline

    Changes in AST levels at Week 24 compared to baseline

    Measured: at Week 24

  27. Percentage changes (%) in ALT levels compared to baseline

    Percentage changes (%) in ALT levels at Week 24 compared to baseline

    Measured: at Week 24

  28. Percentage changes (%) in AST levels compared to baseline

    Percentage changes (%) in AST levels at Week 24 compared to baseline

    Measured: at Week 24

  29. Changes in systolic blood pressure compared to baseline

    Changes in systolic blood pressure at Week 12 compared to baseline

    Measured: at Week 12

  30. Changes in diastolic blood pressure compared to baseline

    Changes in diastolic blood pressure at Week 12 compared to baseline

    Measured: at Week 12

  31. Percentage changes (%) in systolic blood pressure compared to baseline

    Percentage changes (%) in systolic blood pressure at Week 12 compared to baseline

    Measured: at Week 12

  32. Percentage changes (%) in diastolic blood pressure compared to baseline

    Percentage changes (%) in diastolic blood pressure at Week 12 compared to baseline

    Measured: at Week 12

  33. Changes in systolic blood pressure compared to baseline

    Changes in systolic blood pressure at Week 24 compared to baseline

    Measured: at Week 24

  34. Changes in diastolic blood pressure compared to baseline

    Changes in diastolic blood pressure at Week 24 compared to baseline

    Measured: at Week 24

  35. Percentage changes (%) in systolic blood pressure compared to baseline

    Percentage changes (%) in systolic blood pressure at Week 24 compared to baseline

    Measured: at Week 24

  36. Percentage changes (%) in diastolic blood pressure compared to baseline

    Percentage changes (%) in diastolic blood pressure at Week 24 compared to baseline

    Measured: at Week 24

  37. Changes in HbA1c levels compared to baseline

    Changes in HbA1c levels at Week 12 compared to baseline

    Measured: at Week 12

  38. Percentage changes (%) in HbA1c levels compared to baseline

    Percentage changes (%) in HbA1c levels at Week 12 compared to baseline

    Measured: at Week 12

  39. Changes in HbA1c levels compared to baseline

    Changes in HbA1c levels at Week 24 compared to baseline

    Measured: at Week 24

  40. Percentage changes (%) in HbA1c levels compared to baseline

    Percentage changes (%) in HbA1c levels at Week 24 compared to baseline

    Measured: at Week 24

  41. Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels

    Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels

    Measured: at Week 12

  42. Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels

    Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels

    Measured: at Week 12

  43. Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels

    Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels

    Measured: at Week 24

  44. Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels

    Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels

    Measured: at Week 24

  45. Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels

    Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels

    Measured: at Week 12

  46. Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels

    Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels

    Measured: at Week 12

  47. Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels

    Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels

    Measured: at Week 24

  48. Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels

    Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels

    Measured: at Week 24

  49. Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 12

  50. Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 12

  51. Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 24

  52. Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 24

  53. Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 12

  54. Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 12

  55. Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 24

  56. Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

    Measured: at Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start28 Feb 2022
  3. Primary completion31 Dec 2023
  4. Study completion28 Feb 2024

Resources

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
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866509
Sponsor's protocol ID
DWLTV_OS_01
Status last verified
Apr 2025
First submitted
20 Jan 2025
Last updated
17 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemia, 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 10 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 17 Apr 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?

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?

Change in LDL-C Levels Compared to Baseline (time frame: at Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866509.

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 17 Apr 2025.

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