HypertensionPhase 3NCT06643130
Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients With Hypertension and Dyslipidemia
A Phase 3 study testing JW0104+C2402, JW0104+C2403 and C2402 in people with Hypertension and Dyslipidemia, 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 JW0104+C2402 in Patients with Hypertension and Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- JW0104+C2402, JW0104+C2403 and C2402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2024to Apr 2026
- Phase
- Phase 3
- 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 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. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangdong Sacred Heart Hospital
Seoul, 05355
Minjung Kim, +82-2-840-6861, kmj@jwhealthcare.com
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 JW0104+C2402 in Patients With Hypertension and Dyslipidemia
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia
Read the detailed description
To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and dyslipidemia.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- JW0104+C2402, JW0104+C2403, C2402
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JW0104+C2402Drug
Also called NA (Not Applicable)
For 8 weeks(PO (Per Oral), QD)
JW0104+C2403Drug
Also called NA (Not Applicable)
For 8 weeks(PO, QD)
C2402Drug
Also called NA (Not Applicable)
For 8 weeks(PO, QD)
| Study group | Role | What they receive |
|---|---|---|
| JW0104+C2402 | Experimental | JW0104+C2402, 8 weeks, QD (Quaque Die) Receives: Drug: JW0104+C2402 |
| JW0104+C2403 | Active comparator | JW0104+C2403, 8 weeks, QD Receives: Drug: JW0104+C2403 |
| C2402 | Active comparator | C2402, 8 weeks, QD Receives: Drug: C2402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in msSBP (Systolic Blood Pressure)
Check msSBP
Measured: week 8
Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)
Check LDL-C
Measured: week 8
Secondary outcomes (2)
change from baseline in msSBP
Check msSBP
Measured: week 4
Change and percent change from baseline in LDL-C
Check LDL-C
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start2 Dec 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minjung Kim, Study chair, JW Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643130
- Sponsor's protocol ID
- JW24301
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2024
- Last updated
- 9 Sep 2025
- 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 9 Sep 2025. 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 JW0104+C2402 in Patients With Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT06643130
- Acronym / sponsor ID
- JW24301
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Oct 2024 (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 JW0104+C2402 in Patients with Hypertension and Dyslipidemia
Detailed description
To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and dyslipidemia.
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 |
|---|---|---|
| JW0104+C2402 | Experimental | Drug: JW0104+C2402JW0104+C2402, 8 weeks, QD (Quaque Die) |
| JW0104+C2403 | Active comparator | Drug: JW0104+C2403JW0104+C2403, 8 weeks, QD |
| C2402 | Active comparator | Drug: C2402C2402, 8 weeks, QD |
Who may qualify
- Ages
- 19 years and older
- 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 |
|---|---|---|
| JW0104+C2402Also: NA (Not Applicable)For 8 weeks(PO (Per Oral), QD) | Drug | JW0104+C2402 |
| JW0104+C2403Also: NA (Not Applicable)For 8 weeks(PO, QD) | Drug | JW0104+C2403 |
| C2402Also: NA (Not Applicable)For 8 weeks(PO, QD) | Drug | C2402 |
Primary outcome
Change from baseline in msSBP (Systolic Blood Pressure)
Time frame: week 8
Check msSBP
Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)
Time frame: week 8
Check LDL-C
2 secondary outcomes
change from baseline in msSBP
Time frame: week 4
Change and percent change from baseline in LDL-C
Time frame: week 4
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 9 Sep 2025.
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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.
Minjung Kim study chair
JW Pharmaceutical
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 JW0104+C2402, JW0104+C2403 and C2402 in people with Hypertension and Dyslipidemia, 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: looking for participants now, as of the sponsor's last update on 9 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.
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?
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?
Contact Minjung Kim (+82-2-840-6861, kmj@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in msSBP (Systolic Blood Pressure) (time frame: week 8). The study lists 2 primary outcomes in all. 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 9 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.