Hypertension,EssentialPhase 3NCT06291207
A Study to Evaluate the Efficacy and Safety of AD-224
A Phase 3 study testing AD-224A, AD-224B and AD-224C in people with Hypertension,Essential, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of AD-224 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- AD-224A, AD-224B and AD-224C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2024to 7 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusions applied
Who cannot join
- Patient with Secondary Hypertension
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of AD-224
Read the detailed description
Condition or disease : Essential Hypertension
- Conditions
- Hypertension,Essential
- Being tested
- AD-224A, AD-224B, AD-224C, Placebo of AD-224A, Placebo of AD-224B
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-224ADrug
PO, Once daily, 8weeks
AD-224BDrug
PO, Once daily, 8weeks
AD-224CDrug
PO, Once daily, 8weeks
Placebo of AD-224ADrug
PO, Once daily, 8weeks
Placebo of AD-224BDrug
PO, Once daily, 8weeks
Placebo of AD-224CDrug
PO, Once daily, 8weeks
| Study group | Role | What they receive |
|---|---|---|
| AD-224A | Experimental | AD-224A+Placebo of AD-224B+Placebo of AD-224C Receives: Drug: AD-224A; Drug: Placebo of AD-224B; Drug: Placebo of AD-224C |
| AD-224B | Experimental | Placebo of AD-224A+AD-224B+Placebo of AD-224C Receives: Drug: AD-224B; Drug: Placebo of AD-224A; Drug: Placebo of AD-224C |
| AD-224C | Active comparator | Placebo of AD-224A+Placebo of AD-224B+AD-224C Receives: Drug: AD-224C; Drug: Placebo of AD-224A; Drug: Placebo of AD-224B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate of MSSBP
Change from baseline in mean sitting systolic blood pressure
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Apr 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- InHo Chae, M.D., Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291207
- Sponsor's protocol ID
- AD-224P3
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2024
- Last updated
- 3 Aug 2026
- Results posted
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06291207
- Acronym / sponsor ID
- AD-224P3
- Conditions
- Hypertension,Essential
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 4 Mar 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.
The purpose of this study is to evaluate the efficacy and safety of AD-224
Detailed description
Condition or disease : Essential Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AD-224A | Experimental | Drug: AD-224A, Drug: Placebo of AD-224B, Drug: Placebo of AD-224CAD-224A+Placebo of AD-224B+Placebo of AD-224C |
| AD-224B | Experimental | Drug: AD-224B, Drug: Placebo of AD-224A, Drug: Placebo of AD-224CPlacebo of AD-224A+AD-224B+Placebo of AD-224C |
| AD-224C | Active comparator | Drug: AD-224C, Drug: Placebo of AD-224A, Drug: Placebo of AD-224BPlacebo of AD-224A+Placebo of AD-224B+AD-224C |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusions applied
Key exclusion criteria (2 listed)
- Patient with Secondary Hypertension
- Other exclusions applied
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 |
|---|---|---|
| AD-224APO, Once daily, 8weeks | Drug | AD-224A |
| AD-224BPO, Once daily, 8weeks | Drug | AD-224B |
| AD-224CPO, Once daily, 8weeks | Drug | AD-224C |
| Placebo of AD-224APO, Once daily, 8weeks | Drug | AD-224B, AD-224C |
| Placebo of AD-224BPO, Once daily, 8weeks | Drug | AD-224A, AD-224C |
| Placebo of AD-224CPO, Once daily, 8weeks | Drug | AD-224A, AD-224B |
Primary outcome
Change rate of MSSBP
Time frame: Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure
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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
InHo Chae, M.D., Ph.D principal investigator
Seoul National University Bundang 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 AD-224A, AD-224B and AD-224C in people with Hypertension,Essential, run by Addpharma Inc. 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 3 inclusion and 2 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 Aug 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 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 rate of MSSBP (time frame: Baseline, 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 3 Aug 2026.