DyslipidemiaNCT07515560
Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study
An observational study of Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemia
- Type of treatment
- Pill or oral medicine
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged ≥19 years
- Patients diagnosed with dyslipidemia
- Patients who require treatment with Baroezet Tablet
- Patients who provide written informed consent
Who cannot join
- Hypersensitivity to study drug components
- Active liver disease
- Pregnant or breastfeeding women
- Patients considered inappropriate by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Multiple centers in Republic of Korea
Seoul
Yun Jeong Kong, 82-10-3206-5162, yjkong246@daewoong.co.kr
About this study
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
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.
Read the 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
- Keywords
- Dyslipidemia, LDL-C, Statin, Ezetimibe, Observational Study, Real-world
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 24
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline to Week 12
Percent Change in Triglycerides (TG)
Percent change in triglyceride (TG) levels from baseline to approximately 12 weeks.
Measured: 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.
Measured: Baseline to Week 24
Percent Change in Triglycerides (TG)
Percent change in triglyceride (TG) levels from baseline to approximately 24 weeks.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515560
- Sponsor's protocol ID
- DW_BAR_DB_01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07515560
- Acronym / sponsor ID
- DW_BAR_DB_01
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, LDL-C, Statin, Ezetimibe, Observational Study, Real-world
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults aged ≥19 years
- Patients diagnosed with dyslipidemia
- Patients who require treatment with Baroezet Tablet
- Patients who provide written informed consent
Key exclusion criteria (4 listed)
- Hypersensitivity to study drug components
- Active liver disease
- Pregnant or breastfeeding women
- Patients considered inappropriate by investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Change in LDL-C from Baseline to Week 24
Time frame: Baseline to Week 24
Percent change in LDL-C levels from baseline to approximately 24 weeks after treatment initiation.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Jeong Kong (82-10-3206-5162, yjkong246@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in LDL-C from Baseline to Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.