HypercholesterolemiaPhase 4NCT07442630
Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides
A Phase 4 study testing Pitavastatin 4mg and Ezetimibe 10 mg in people with Hypercholesterolemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Pitavastatin 4mg and Ezetimibe 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2023to 30 Nov 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with hypercholesterolemia
- Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C
Who cannot join
- New-onset acute cardio-cerebrovascular disease
- Severe hepatic impairment
- Active liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
About this study
Official title: A Multicenter Study to Evaluate Efficacy and Safety
A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides
Read the detailed description
A multicenter study to evaluate efficacy and safety
- Conditions
- Hypercholesterolemia
- Being tested
- Pitavastatin 4mg, Ezetimibe 10 mg, Placebo (for Pitavastatin/Ezetimibe), Placebo (for Pitavastatin)
- Keywords
- LDL Cholesterol Reduction
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin 4mgDrug
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Ezetimibe 10 mgDrug
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Placebo (for Pitavastatin/Ezetimibe)Drug
Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks.
Placebo (for Pitavastatin)Drug
Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin/Ezetimibe Combination | Experimental | FDC of Pitavastatin/Ezetimibe Receives: Drug: Pitavastatin 4mg; Drug: Ezetimibe 10 mg; Drug: Placebo (for Pitavastatin) |
| Pitavastatin Monotherapy | Active comparator | Pitavastatin Receives: Drug: Pitavastatin 4mg; Drug: Placebo (for Pitavastatin/Ezetimibe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment
The unit of measure is percentage (%). The percentage change is calculated as: [(Value at Week 8 - Value at Baseline) / Value at Baseline] * 100
Measured: Baseline to week 8
Secondary outcomes (4)
Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Measured: Baseline to week 8, 24, 52
Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Measured: Baseline to week 8, 24, 52
Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Measured: Baseline to week 8, 24, 52
Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52
The NLFS is a calculated score used to estimate liver fat content. The change is calculated as (Value at Week 24 or 52) - (Value at Baseline).
Measured: Baseline to week 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start21 Aug 2023
- Primary completion22 Jan 2026
- Study completion30 Nov 2026 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, phase IV
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyuk Sang Kwon, Principal investigator, The Catholic University of Korea, Yeouido St. Mary's Hospital, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442630
- Sponsor's protocol ID
- JW22401
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 2 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07442630
- Acronym / sponsor ID
- JW22401
- Conditions
- Hypercholesterolemia
- Keywords
- LDL Cholesterol Reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 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 multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides
Detailed description
A multicenter study to evaluate efficacy and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, phase IV
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin/Ezetimibe Combination | Experimental | Drug: Pitavastatin 4mg, Drug: Ezetimibe 10 mg, Drug: Placebo (for Pitavastatin)FDC of Pitavastatin/Ezetimibe |
| Pitavastatin Monotherapy | Active comparator | Drug: Pitavastatin 4mg, Drug: Placebo (for Pitavastatin/Ezetimibe)Pitavastatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hypercholesterolemia
- Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C
Key exclusion criteria (3 listed)
- New-onset acute cardio-cerebrovascular disease
- Severe hepatic impairment
- Active liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin 4mgAdministered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks. | Drug | Pitavastatin Monotherapy, Pitavastatin/Ezetimibe Combination |
| Ezetimibe 10 mgAdministered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks. | Drug | Pitavastatin/Ezetimibe Combination |
| Placebo (for Pitavastatin/Ezetimibe)Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks. | Drug | Pitavastatin Monotherapy |
| Placebo (for Pitavastatin)Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks. | Drug | Pitavastatin/Ezetimibe Combination |
Primary outcome
Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment
Time frame: Baseline to week 8
The unit of measure is percentage (%). The percentage change is calculated as: [(Value at Week 8 - Value at Baseline) / Value at Baseline] * 100
4 secondary outcomes
Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Time frame: Baseline to week 8, 24, 52
Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment
Time frame: Baseline to week 8, 24, 52
Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Time frame: Baseline to week 8, 24, 52
Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52
Time frame: Baseline to week 24, 52
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 2 Mar 2026.
- Individual participant dataSharing planned: No
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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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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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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.
Hyuk Sang Kwon principal investigator
The Catholic University of Korea, Yeouido St. Mary's Hospital, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin 4mg and Ezetimibe 10 mg in people with 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment (time frame: Baseline to week 8). 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 2 Mar 2026.