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Completed

NCT Number: NCT06866509

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Litorvazet Tablet 10/10mg

Drug

Ezetimibe 10 mg + Atorvastatin 10 mg

Litorvazet Tablet10/20mg

Drug

Ezetimibe 10 mg + Atorvastatin 20 mg

Litorvazet Tablet 10/40mg

Drug

Ezetimibe 10 mg + Atorvastatin 40 mg

Primary outcomes

  1. Change in LDL-C Levels Compared to Baseline

    Time frame: at Week 24

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

Secondary outcomes

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

  5. Changes in HDL-C levels compared to baseline

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

  7. Changes in HDL-C levels compared to baseline

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

  13. Changes in TG levels compared to baseline

    Time frame: at Week 12

    Changes in TG levels at Week 12 compared to baseline.

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

    Time frame: at Week 12

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

  15. Changes in TG levels compared to baseline

    Time frame: at Week 24

    Changes in TG levels at Week 24 compared to baseline

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

    Time frame: at Week 24

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

  17. Changes in TC levels compared to baseline

    Time frame: at Week 12

    Changes in TC levels at Week 12 compared to baseline

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

    Time frame: at Week 12

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

  19. Changes in TC levels compared to baseline

    Time frame: at Week 24

    Changes in TC levels at Week 24 compared to baseline

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

    Time frame: at Week 24

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

  21. Changes in ALT levels compared to baseline

    Time frame: at Week 12

    Changes in ALT levels at Week 12 compared to baseline

  22. Changes in AST levels compared to baseline

    Time frame: at Week 12

    Changes in AST levels at Week 12 compared to baseline

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

  25. Changes in ALT levels compared to baseline

    Time frame: at Week 24

    Changes in ALT levels at Week 24 compared to baseline

  26. Changes in AST levels compared to baseline

    Time frame: at Week 24

    Changes in AST levels at Week 24 compared to baseline

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

  29. Changes in systolic blood pressure compared to baseline

    Time frame: at Week 12

    Changes in systolic blood pressure at Week 12 compared to baseline

  30. Changes in diastolic blood pressure compared to baseline

    Time frame: at Week 12

    Changes in diastolic blood pressure at Week 12 compared to baseline

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

  33. Changes in systolic blood pressure compared to baseline

    Time frame: at Week 24

    Changes in systolic blood pressure at Week 24 compared to baseline

  34. Changes in diastolic blood pressure compared to baseline

    Time frame: at Week 24

    Changes in diastolic blood pressure at Week 24 compared to baseline

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

  37. Changes in HbA1c levels compared to baseline

    Time frame: at Week 12

    Changes in HbA1c levels at Week 12 compared to baseline

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

    Time frame: at Week 12

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

  39. Changes in HbA1c levels compared to baseline

    Time frame: at Week 24

    Changes in HbA1c levels at Week 24 compared to baseline

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

    Time frame: at Week 24

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 12

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

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

    Time frame: at Week 24

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

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

    Time frame: at Week 24

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

  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

    Time frame: at Week 12

    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

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

    Time frame: at Week 12

    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

  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

    Time frame: at Week 24

    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

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

    Time frame: at Week 24

    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

  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

    Time frame: at Week 12

    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

  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

    Time frame: at Week 12

    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

  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

    Time frame: at Week 24

    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

  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

    Time frame: at Week 24

    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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 10, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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