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

ConditionDyslipidemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥19 years

Patients diagnosed with dyslipidemia

Patients who require treatment with Baroezet Tablet

Patients who provide written informed consent

Disqualifiers

Hypersensitivity to study drug components

Active liver disease

Pregnant or breastfeeding women

Patients considered inappropriate by investigator

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

12,000 Participants
are grouped into 1 trial group
Group A: Baroezet Treatment Group

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to Week 24

Secondary outcomes

1

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.

Time frame
Baseline to Week 12
2

Percent Change in Total Cholesterol (TC)

Percent change in total cholesterol (TC) from baseline to approximately 12 weeks after treatment initiation.

Time frame
Baseline to Week 12
3

Percent Change in Triglycerides (TG)

Percent change in triglyceride (TG) levels from baseline to approximately 12 weeks.

Time frame
Baseline to Week 12
4

Percent Change in Total Cholesterol (TC)

Percent change in total cholesterol (TC) from baseline to approximately 24 weeks after treatment initiation.

Time frame
Baseline to Week 24

Other outcomes

Sponsors and contacts

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