DyslipidemiaPhase 3NCT05331014
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
A Phase 3 study testing LivaloVA, LivaloV and VA in people with Dyslipidemia and Hypertension, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Dyslipidemia, Hypertension
- What is being tested?
- LivaloVA, LivaloV and VA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2021to 8 Nov 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension and dyslipidemia
Who cannot join
- The subject not meet the specified msBP and LDL-C level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.
A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.
Read the detailed description
Multicenter, randomized, double-blind, parallel-design, phase III clinical study
- Conditions
- Dyslipidemia, Hypertension
- Being tested
- LivaloVA, LivaloV, VA
- Medical subject headings
- Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LivaloVADrug
Also called JW0101+C2101
For 8 weeks(PO, QD)
LivaloVDrug
Also called JW0101+C2102
For 8 weeks(PO, QD)
VADrug
Also called C2101
For 8 weeks(PO, QD)
| Study group | Role | What they receive |
|---|---|---|
| JW0101+C2101 | Experimental | LivaloVA Receives: Drug: LivaloVA |
| JW0101+C2102 | Active comparator | LivaloV Receives: Drug: LivaloV |
| C2101 | Active comparator | VA Receives: Drug: VA |
What is being measured
The primary outcome is the main question the study is designed to answer.
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
change in msSBP and LDL-C level
Measured: week 8
Secondary outcomes (1)
efficacy and safety
change in msSBP and LDL-C level
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Nov 2021
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gyurok Han, CI, Principal investigator, Gangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331014
- Sponsor's protocol ID
- JWP-PVA-301
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.
- ClinicalTrials.gov ID
- NCT05331014
- Acronym / sponsor ID
- JWP-PVA-301
- Conditions
- Dyslipidemia, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 15 Apr 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.
A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.
Detailed description
Multicenter, randomized, double-blind, parallel-design, phase III clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JW0101+C2101 | Experimental | Drug: LivaloVALivaloVA |
| JW0101+C2102 | Active comparator | Drug: LivaloVLivaloV |
| C2101 | Active comparator | Drug: VAVA |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hypertension and dyslipidemia
Key exclusion criteria (1 listed)
- The subject not meet the specified msBP and 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 |
|---|---|---|
| LivaloVAAlso: JW0101+C2101For 8 weeks(PO, QD) | Drug | JW0101+C2101 |
| LivaloVAlso: JW0101+C2102For 8 weeks(PO, QD) | Drug | JW0101+C2102 |
| VAAlso: C2101For 8 weeks(PO, QD) | Drug | C2101 |
Primary outcome
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
Time frame: week 8
change in msSBP and LDL-C level
1 secondary outcome
efficacy and safety
Time frame: 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 15 Mar 2024.
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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.
Gyurok Han, CI principal investigator
Gangdong Sacred Heart Hospital
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 LivaloVA, LivaloV and VA in people with Dyslipidemia and Hypertension, 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 15 Mar 2024. 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?
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect (time frame: 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 15 Mar 2024.