Clinical trial NCT06866509: To Investigate Blood Lipid Changes and Safety After Litorvazet® Tablets in Dyslipidemia Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in LDL-C Levels Compared to Baseline
timeFrame: at Week 24
Secondary outcomes:
measure: Changes in LDL-C levels compared to baseline [excluding primary endpoints].
timeFrame: at Week 12
measure: Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].
timeFrame: at Week 12
measure: Changes in LDL-C levels compared to baseline [excluding primary endpoints].
timeFrame: at Week 24
measure: Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].
timeFrame: at Week 24
measure: Changes in HDL-C levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in HDL-C levels compared to baseline
timeFrame: at Week 12
measure: Changes in HDL-C levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in HDL-C levels compared to baseline
timeFrame: at Week 24
measure: Changes in Non-HDL-C levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in Non-HDL-C levels compared to baseline
timeFrame: at Week 12
measure: Changes in Non-HDL-C levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in Non-HDL-C levels compared to baseline
timeFrame: at Week 24
measure: Changes in TG levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in TG levels compared to baseline
timeFrame: at Week 12
measure: Changes in TG levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in TG levels compared to baseline
timeFrame: at Week 24
measure: Changes in TC levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in TC levels compared to baseline
timeFrame: at Week 12
measure: Changes in TC levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in TC levels compared to baseline
timeFrame: at Week 24
measure: Changes in ALT levels compared to baseline
timeFrame: at Week 12
measure: Changes in AST levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in ALT levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in AST levels compared to baseline
timeFrame: at Week 12
measure: Changes in ALT levels compared to baseline
timeFrame: at Week 24
measure: Changes in AST levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in ALT levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in AST levels compared to baseline
timeFrame: at Week 24
measure: Changes in systolic blood pressure compared to baseline
timeFrame: at Week 12
measure: Changes in diastolic blood pressure compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in systolic blood pressure compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in diastolic blood pressure compared to baseline
timeFrame: at Week 12
measure: Changes in systolic blood pressure compared to baseline
timeFrame: at Week 24
measure: Changes in diastolic blood pressure compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in systolic blood pressure compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in diastolic blood pressure compared to baseline
timeFrame: at Week 24
measure: Changes in HbA1c levels compared to baseline
timeFrame: at Week 12
measure: Percentage changes (%) in HbA1c levels compared to baseline
timeFrame: at Week 12
measure: Changes in HbA1c levels compared to baseline
timeFrame: at Week 24
measure: Percentage changes (%) in HbA1c levels compared to baseline
timeFrame: at Week 24
measure: Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels
timeFrame: at Week 12
measure: Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels
timeFrame: at Week 12
measure: Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels
timeFrame: at Week 24
measure: Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels
timeFrame: at Week 24
measure: Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels
timeFrame: at Week 12
measure: Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels
timeFrame: at Week 12
measure: Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels
timeFrame: at Week 24
measure: Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels
timeFrame: at Week 24
measure: Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 12
measure: Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 12
measure: Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 24
measure: Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 24
measure: 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
timeFrame: at Week 12
measure: Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 12
measure: 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
timeFrame: at Week 24
measure: Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment
timeFrame: at Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sung-Mi Park, Dr.
role: PRINCIPAL_INVESTIGATOR
References: