Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dyslipidemia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Percent Change in LDL-C from Baseline to Week 24 [Time frame: Baseline to Week 24]
Secondary outcome measures (5)
- Percent Change in LDL-C at Week 12 [Time frame: Baseline to Week 12]
- Percent Change in Total Cholesterol (TC) [Time frame: Baseline to Week 12]
- Percent Change in Triglycerides (TG) [Time frame: Baseline to Week 12]
- Percent Change in Total Cholesterol (TC) [Time frame: Baseline to Week 24]
- Percent Change in Triglycerides (TG) [Time frame: Baseline to Week 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Multiple centers in Republic of Korea — Seoul
Identifiers
NCT: NCT07515560 · DW_BAR_DB_01