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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07515560

Enrollment

12000

Registered

2026-04-07

Start date

2026-04-30

Completion date

2027-12-31

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Dyslipidemia, LDL-C, Statin, Ezetimibe, Observational Study, Real-world

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

CONTACTYun Jeong Kong

yjkong246@daewoong.co.kr82-10-3206-5162

Outcome results