Primary HypercholesterolemiaLITENCT05559606
An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
An observational study of Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Hypercholesterolemia
- How many people
- 1,839 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Sep 2022to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with primary hypercholesterolemia that require a fixed dose combination therapy with Atorvastatin and Ezetimibe
Who may be able to join
- Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
- Any male/female subjects 19 years old or older.
- Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia.
- Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration.
- Those who failed to reach to the target LDL-C level per risk group based on the risk group classification specified in the therapeutic guideline for dyslipidemia (2018).
- [Risk Group, Target LDL-C (mg/dL) Level]
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- Very High Risk <70
- Coronary artery disease
- Atherosclerotic ischemic stroke and transient cerebral ischemic attack
- Peripheral arterial disease
- High Risk <100
- Carotid disease (When significant carotid artery stenosis is diagnosed)
- Abdominal aneurysm
- Diabetes (For patients with major risk factors such as damage to target organs or cardiovascular diseases, the target level may be lowered based on the patient conditions)
- Moderate Risk <130
- 2 or more major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
- Low Risk <160
- 1 or less major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
- Those who fully understand the clinical trial, are cooperative throughout the trial and capable of participating in the trial until it ends.
Who cannot join
- Those who are hypersensitive to major ingredients or other ingredients of the investigational drug.
- Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions.
- Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)).
- Patients with serious nephropathy.
- Those who have medical history of myopathy and rhabdomyolysis.
- Female patients who are pregnant, suspected to be pregnant or breastfeeding.
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- Those who are administrating glecaprevir and pibrentasvir.
- The drug contains lactose, thus those who have genetic problems, including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
- Those who are currently participating in other clinical trials (any trials with drugs or medical devices) or who have been administered with investigational drugs of other clinical trials within 4 weeks from the baseline. However, those participating in non-interventional trials or being observed after the drug administration is complete may take part in the trial.
- Those who are currently hospitalized or are expected to be hospitalized.
- Those who are suffering from severe or unstable medical and mental illnesses that may impact the trial as assessed by the investigators.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: An Observational Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe in Real World Patients With Primary Hypercholesterolemia
The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe.
Read the detailed description
The prevalence of hypercholesterolemia, an atherosclerotic dyslipidemia which is the major cause of coronary artery diseases has risen. According to numerous studies, LDL-C is the key cause of atherosclerosis and it has been reported that treating patients to lower the LDL-C level will reduce the incidence of cardiovascular diseases. Currently, patients are classified into risk groups to receive a recommended therapy based on the defined criteria in Korea and Statin is the primary therapeutic agent recommended. However, there have been concerns that an increased dose of statins may result in hepatoxicity and reports that a combination therapy with ezetimibe without an additional dose of statins has clinical benefits. Ezetimibe is a drug that inhibits cholesterol absorption in the small intestine and reduces the LDL-C level. The therapeutic guideline, first of all, recommends combination therapy with ezetimibe among other drugs whose clinical benefits have been confirmed in cases where the target LDL-C level is not met with statins.
The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe.
During this study period, the scope of data to be collected is as follows:
- Demographic data
- Indication diagnosis and characteristics
- Cardiovascular risk
- Medical history
- Statin medication
- Preceding/Concomitant drug
- Administration of fixed dose combination therapy with atorvastatin and ezetimibe
- Collecting efficacy endpoints: Lipid profile(LDL-C, TC, TG, HDL-C, non-HDL-C)
- Collecting safety endpoints: ADR, SAE, SADR, HbA1C, FPG, AST, ALT, CPK
- Conditions
- Primary Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Atorvastatin, Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reaching the target LDL-C level
Rate of reaching the target LDL-C level at Week 24
Measured: Week 24
Secondary outcomes (2)
Rate of reaching the target LDL-C level
Rate of reaching the target LDL-C level at Week 12
Measured: Week 12
Rate of change compared to the baseline when it comes to the level of TC, TG, LDL-C, HDL-C and non-HDL-C
Rate of change at Week 12 and Week 24 compared to the baseline when it comes to the level of TC, TG, LDL-C, HDL-C and non-HDL-C
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start7 Sep 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- 1,839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MyungSook Hong, Study director, Boryung Co.,Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559606
- Sponsor's protocol ID
- BR-EAC-OS-401
- Acronym
- LITE
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe in Real World Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05559606
- Acronym / sponsor ID
- LITE / BR-EAC-OS-401
- Conditions
- Primary Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Atorvastatin, Ezetimibe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,839 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Sep 2022 (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.
The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe.
Detailed description
The prevalence of hypercholesterolemia, an atherosclerotic dyslipidemia which is the major cause of coronary artery diseases has risen. According to numerous studies, LDL-C is the key cause of atherosclerosis and it has been reported that treating patients to lower the LDL-C level will reduce the incidence of cardiovascular diseases. Currently, patients are classified into risk groups to receive a recommended therapy based on the defined criteria in Korea and Statin is the primary therapeutic agent recommended. However, there have been concerns that an increased dose of statins may result in hepatoxicity and reports that a combination therapy with ezetimibe without an additional dose of statins has clinical benefits. Ezetimibe is a drug that inhibits cholesterol absorption in the small intestine and reduces the LDL-C level. The therapeutic guideline, first of all, recommends combination therapy with ezetimibe among other drugs whose clinical benefits have been confirmed in cases where the target LDL-C level is not met with statins.
The study observes real world patients with primary hypercholesterolemia who receive a fixed dose combination therapy with atorvastatin and ezetimibe for 24 weeks; collects and analyzes data related to efficacy and safety of the therapy; and evaluates efficacy and safety of the fixed dose combination therapy with atorvastatin and ezetimibe.
During this study period, the scope of data to be collected is as follows:
- Demographic data
- Indication diagnosis and characteristics
- Cardiovascular risk
- Medical history
- Statin medication
- Preceding/Concomitant drug
- Administration of fixed dose combination therapy with atorvastatin and ezetimibe
- Collecting efficacy endpoints: Lipid profile(LDL-C, TC, TG, HDL-C, non-HDL-C)
- Collecting safety endpoints: ADR, SAE, SADR, HbA1C, FPG, AST, ALT, CPK
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary hypercholesterolemia that require a fixed dose combination therapy with Atorvastatin and Ezetimibe
Key inclusion criteria (19 listed)
- Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
- Any male/female subjects 19 years old or older.
- Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia.
- Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration.
- Those who failed to reach to the target LDL-C level per risk group based on the risk group classification specified in the therapeutic guideline for dyslipidemia (2018).
Key exclusion criteria (11 listed)
- Those who are hypersensitive to major ingredients or other ingredients of the investigational drug.
- Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions.
- Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)).
- Patients with serious nephropathy.
- Those who have medical history of myopathy and rhabdomyolysis.
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
Rate of reaching the target LDL-C level
Time frame: Week 24
Rate of reaching the target LDL-C level at Week 24
2 secondary outcomes
Rate of reaching the target LDL-C level
Time frame: Week 12
Rate of change compared to the baseline when it comes to the level of TC, TG, LDL-C, HDL-C and non-HDL-C
Time frame: Week 12 and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
MyungSook Hong study director
Boryung Co.,Ltd.
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 Primary Hypercholesterolemia, run by Boryung 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 19 inclusion and 11 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: finished, as of the sponsor's last update on 12 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reaching the target LDL-C level (time frame: 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 12 Sep 2025.