NCT07515560

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
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-03-01
• Completion: 2027-12-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: South Korea