Primary HypercholesterolemiaPhase 3NCT04584736
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
A Phase 3 study testing Livalo, Ezetrol in people with Primary Hypercholesterolemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- Livalo, Ezetrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2019to 12 Oct 2020
- Phase
- Phase 3
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary hypercholesterolemia
Who cannot join
- The subject not meet the specified LDL-C level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
Read the detailed description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
- Conditions
- Primary Hypercholesterolemia
- Being tested
- Livalo, Ezetrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livalo, EzetrolDrug
Also called Pitavastatin, Ezetimibe
Pitavastatin+Ezetimibe Pitavastatin
| Study group | Role | What they receive |
|---|---|---|
| Livalo 2mg, Ezetrol 10mg | Experimental | Pitavastatin 2mg, Ezetimibe 10mg Receives: Drug: Livalo, Ezetrol |
| Livalo 2mg | Active comparator | Pitavastatin 2mg Receives: Drug: Livalo, Ezetrol |
| Livalo 4mg, Ezetrol 10mg | Experimental | Pitavastatin 4mg, Ezetimibe 10mg Receives: Drug: Livalo, Ezetrol |
| Livalo 4mg | Active comparator | Pitavastatin 4mg Receives: Drug: Livalo, Ezetrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change in LDL-C level from baseline at Week 8
change in LDL-C level
Measured: Week 8
Secondary outcomes (1)
Change in LDL-C level from baseline at Week 4 and Week 8
change in LDL-C level
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start11 Jun 2019
- Primary completion16 Jul 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- dongryeong lee, Manager, Study chair, +82-2-840-6982
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584736
- Sponsor's protocol ID
- JWP-PTZ-301
- Status last verified
- Aug 2020
- First submitted
- 6 Oct 2020
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.
PubMed 36241463
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04584736
- Acronym / sponsor ID
- JWP-PTZ-301
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 14 Oct 2020 (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.
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
Detailed description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Livalo 2mg, Ezetrol 10mg | Experimental | Drug: Livalo, EzetrolPitavastatin 2mg, Ezetimibe 10mg |
| Livalo 2mg | Active comparator | Drug: Livalo, EzetrolPitavastatin 2mg |
| Livalo 4mg, Ezetrol 10mg | Experimental | Drug: Livalo, EzetrolPitavastatin 4mg, Ezetimibe 10mg |
| Livalo 4mg | Active comparator | Drug: Livalo, EzetrolPitavastatin 4mg |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary hypercholesterolemia
Key exclusion criteria (1 listed)
- The subject not meet the specified LDL-C level
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 |
|---|---|---|
| Livalo, EzetrolAlso: Pitavastatin, EzetimibePitavastatin+Ezetimibe Pitavastatin | Drug | Livalo 2mg, Livalo 2mg, Ezetrol 10mg, Livalo 4mg, Livalo 4mg, Ezetrol 10mg |
Primary outcome
% change in LDL-C level from baseline at Week 8
Time frame: Week 8
change in LDL-C level
1 secondary outcome
Change in LDL-C level from baseline at Week 4 and Week 8
Time frame: Week 4 and Week 8
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 1 Dec 2021.
- Derived from this study: PubMed 36241463Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.
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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.
dongryeong lee, Manager study chair
+82-2-840-6982
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Livalo, Ezetrol in people with Primary 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 1 inclusion and 1 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 1 Dec 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
% change in LDL-C level from baseline at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584736, which also lists 1 linked publication.
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 1 Dec 2021.