HypercholesterolemiaNCT07445542
Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
An observational study of Hypercholesterolemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 6,927 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Dec 2021to 13 May 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: The study population includes adult patients (≥19 years) with hypercholesterolemia who are receiving routine clinical care at multiple centers in South Korea. The participants are those who have maintained a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe as determined by the investigator. This observational study aims to reflect real-world clinical outcomes in patients undergoing this medication switch, provided they meet all eligibility criteria and provide written informed consent.
Who may be able to join
- Adults (≥19 years) with hypercholesterolemia.
- On a stable dose of statin monotherapy for at least 8 weeks.
- Scheduled to switch to Pitavastatin/Ezetimibe per investigator's decision.
- Provided voluntary written informed consent.
Who cannot join
- Use of other lipid-lowering therapies within 4 weeks before screening.
- History of clinically significant laboratory abnormalities within 1 year.
- Participation in other clinical trials within 4 weeks.
- Contraindications to Pitavastatin/Ezetimibe
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
About this study
Official title: A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia
Read the detailed description
A Multi-center, Open-label, Observational Study
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Dyslipidemia, Statin Monotherapy, LDL Cholesterol, Pitavastatin and Ezetimibe Combination, Observational Study, Switching Study
- Medical subject headings
- Hypercholesterolemia, 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 |
|---|---|---|
| switching to a fixed-dose combination of pitavastatin and ezetimibe | Patients with hypercholesterolemia who have been treated with a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C level
Percent change from baseline in LDL-C level at Week 24
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start18 Dec 2021
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- 6,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445542
- Sponsor's protocol ID
- JW21402
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07445542
- Acronym / sponsor ID
- JW21402
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Dyslipidemia, Statin Monotherapy, LDL Cholesterol, Pitavastatin and Ezetimibe Combination, Observational Study, Switching Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,927 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 3 Mar 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.
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia
Detailed description
A Multi-center, Open-label, Observational Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| switching to a fixed-dose combination of pitavastatin and ezetimibe | – | –Patients with hypercholesterolemia who have been treated with a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients (≥19 years) with hypercholesterolemia who are receiving routine clinical care at multiple centers in South Korea. The participants are those who have maintained a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe as determined by the investigator. This observational study aims to reflect real-world clinical outcomes in patients undergoing this medication switch, provided they meet all eligibility criteria and provide written informed consent.
Key inclusion criteria (4 listed)
- Adults (≥19 years) with hypercholesterolemia.
- On a stable dose of statin monotherapy for at least 8 weeks.
- Scheduled to switch to Pitavastatin/Ezetimibe per investigator's decision.
- Provided voluntary written informed consent.
Key exclusion criteria (4 listed)
- Use of other lipid-lowering therapies within 4 weeks before screening.
- History of clinically significant laboratory abnormalities within 1 year.
- Participation in other clinical trials within 4 weeks.
- Contraindications to Pitavastatin/Ezetimibe
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
LDL-C level
Time frame: From enrollment to the end of treatment at 24 weeks
Percent change from baseline in LDL-C level at 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 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypercholesterolemia, run by JW Pharmaceutical 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: finished, as of the sponsor's last update on 3 Mar 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?
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?
LDL-C level (time frame: From enrollment to the end of treatment at 24 weeks). 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 3 Mar 2026.