Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study

A Prospective, Non-interventional, Multi-center Observational Study to Evaluate the Efficacy and Safety of Baroezet Tablet 1/10 mg in Korean Patients With Dyslipidemia

This study is a prospective, non-interventional, multi-center observational study to evaluate the efficacy and safety of Baroezet Tablet 1/10 mg in Korean patients with dyslipidemia in real-world clinical practice.

Patients who are prescribed Baroezet Tablet according to the physician's clinical judgment will be followed for approximately 24 weeks. The study will assess changes in lipid profiles, including LDL-C, as well as safety outcomes such as adverse events.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidemia

Detailed Description

This study is a prospective, non-interventional, multi-center observational study conducted in Korea to evaluate the efficacy and safety of Baroezet Tablet 1/10 mg (Pitavastatin calcium/Ezetimibe) in patients with dyslipidemia in routine clinical practice.

Eligible patients aged 19 years or older who require treatment with Baroezet Tablet will be enrolled after providing written informed consent. Treatment decisions, including dosage and duration, will be made at the discretion of the treating physician in accordance with approved labeling.

Data will be collected at baseline, approximately 12 weeks, and 24 weeks, based on routine clinical visits. The primary efficacy endpoint is the percent change in LDL-C from baseline to 24 weeks. Secondary endpoints include changes in lipid parameters (TC, TG, HDL-C, non-HDL-C), HbA1c, and achievement of LDL-C targets according to risk categories.

Safety will be assessed by monitoring adverse events and laboratory abnormalities, including liver enzymes and creatine kinase levels.

Approximately 15,000 patients will be enrolled across multiple centers in Korea.

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Yun Jeong Kong; Phone Number: 82-10-3206-5162; Email: yjkong246@daewoong.co.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Multiple centers in Republic of Korea
    • Contact: Yun Jeong Kong; Phone Number: 82-10-3206-5162; Email: yjkong246@daewoong.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will enroll adult patients aged 19 years or older who are diagnosed with dyslipidemia in routine clinical practice in Korea. Eligible patients are those who require treatment with Baroezet Tablet 1/10 mg based on the physician's clinical judgment and provide written informed consent.

Patients will be recruited from multiple centers across Korea in a real-world setting. Treatment decisions, including initiation and continuation of Baroezet Tablet, will be made according to routine clinical practice. Patients with contraindications to the study drug, including hypersensitivity to its components, active liver disease, or pregnancy, will be excluded.

Description

Inclusion Criteria:

• Adults aged ≥19 years
• Patients diagnosed with dyslipidemia
• Patients who require treatment with Baroezet Tablet
• Patients who provide written informed consent

Exclusion Criteria:

• Hypersensitivity to study drug components
• Active liver disease
• Pregnant or breastfeeding women
• Patients considered inappropriate by investigator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Baroezet Treatment Group; Patients with dyslipidemia who are prescribed Baroezet Tablet 1/10 mg according to routine clinical practice will be observed for approximately 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in LDL-C from Baseline to Week 24	Percent change in LDL-C levels from baseline to approximately 24 weeks after treatment initiation.	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in LDL-C at Week 12	Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to approximately 12 weeks after treatment initiation.	Baseline to Week 12
Percent Change in Total Cholesterol (TC)	Percent change in total cholesterol (TC) from baseline to approximately 12 weeks after treatment initiation.	Baseline to Week 12
Percent Change in Triglycerides (TG)	Percent change in triglyceride (TG) levels from baseline to approximately 12 weeks.	Baseline to Week 12
Percent Change in Total Cholesterol (TC)	Percent change in total cholesterol (TC) from baseline to approximately 24 weeks after treatment initiation.	Baseline to Week 24
Percent Change in Triglycerides (TG)	Percent change in triglyceride (TG) levels from baseline to approximately 24 weeks.	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dyslipidemia; Observational Study; Statin; LDL-C; Ezetimibe; Real-world
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias
• Other Study ID Numbers: DW_BAR_DB_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No