Hypertension,EssentialPhase 3NCT06052748
A Study to Evaluate the Efficacy and Safety of AD-223
A Phase 3 study testing AD-223A, AD-223B and AD-223C 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-223 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-223A, AD-223B and AD-223C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2024to 2 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
- Other inclusions applied
Who cannot join
- Orthostatic hypotension with symptom
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of AD-223
Read the detailed description
Condition or disease : hypertension
- Conditions
- Hypertension,Essential
- Being tested
- AD-223A, AD-223B, AD-223C, AD-223A Placebo, AD-223B Placebo
- 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-223ADrug
PO, Once daily(QD), 8weeks
AD-223BDrug
PO, Once daily(QD), 8weeks
AD-223CDrug
PO, Once daily(QD), 8weeks
AD-223A PlaceboDrug
PO, Once daily(QD), 8weeks
AD-223B PlaceboDrug
PO, Once daily(QD), 8weeks
AD-223C PlaceboDrug
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | AD-223A+AD-223B+AD-223C Placebo Receives: Drug: AD-223A; Drug: AD-223B; Drug: AD-223C Placebo |
| Control group 1 | Active comparator | AD-223A+AD-223B Placebo+AD-223C Placebo Receives: Drug: AD-223A; Drug: AD-223B Placebo; Drug: AD-223C Placebo |
| Control group 2 | Active comparator | AD-223A Placebo+AD-223B+AD-223C Placebo Receives: Drug: AD-223B; Drug: AD-223A Placebo; Drug: AD-223C Placebo |
| Control group 3 | Active comparator | AD-223A Placebo+AD-223B Placebo+AD-223C Receives: Drug: AD-223C; Drug: AD-223A Placebo; Drug: AD-223B Placebo |
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 posted25 Sep 2023
- Study start15 Feb 2024
- Primary completion27 Mar 2025
- Study completion2 Apr 2025
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 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
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Ho Shin, M.D., Ph.D, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052748
- Sponsor's protocol ID
- AD-223P3
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn HS, Ahn JC, Cho JM, Lim KH, Han SH, Cho YK, Kim KH, Hong SJ, Lee CJ, Na JO, Sung KC, Choi K, Kim SY, Kim DH, Lee HC, Ihm SH, Youn JC, Choi JY, Kim SH, Kim KI, Sung JH, Pyun WB, Kim WS, Cho JS, Lee Y, Her SH, Cho EJ, Lee EM, Lee HY, Yoon YW, Lee JH, Kim W, Rhee SJ, Shin J. Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial. J Clin Hypertens (Greenwich). 2026 May;28(5):e70279. doi: 10.1111/jch.70279.
PubMed 42130156
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06052748
- Acronym / sponsor ID
- AD-223P3
- Conditions
- Hypertension,Essential
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 25 Sep 2023 (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-223
Detailed description
Condition or disease : hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: AD-223A, Drug: AD-223B, Drug: AD-223C PlaceboAD-223A+AD-223B+AD-223C Placebo |
| Control group 1 | Active comparator | Drug: AD-223A, Drug: AD-223B Placebo, Drug: AD-223C PlaceboAD-223A+AD-223B Placebo+AD-223C Placebo |
| Control group 2 | Active comparator | Drug: AD-223B, Drug: AD-223A Placebo, Drug: AD-223C PlaceboAD-223A Placebo+AD-223B+AD-223C Placebo |
| Control group 3 | Active comparator | Drug: AD-223C, Drug: AD-223A Placebo, Drug: AD-223B PlaceboAD-223A Placebo+AD-223B Placebo+AD-223C |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Other inclusions applied
Key exclusion criteria (2 listed)
- Orthostatic hypotension with symptom
- 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-223APO, Once daily(QD), 8weeks | Drug | Control group 1, Test group |
| AD-223BPO, Once daily(QD), 8weeks | Drug | Control group 2, Test group |
| AD-223CPO, Once daily(QD), 8weeks | Drug | Control group 3 |
| AD-223A PlaceboPO, Once daily(QD), 8weeks | Drug | Control group 2, Control group 3 |
| AD-223B PlaceboPO, Once daily(QD), 8weeks | Drug | Control group 1, Control group 3 |
| AD-223C PlaceboPO, Once daily(QD), 8weeks | Drug | Control group 1, Control group 2, Test group |
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 4 Apr 2025.
- Derived from this study: PubMed 42130156Ahn HS, Ahn JC, Cho JM, Lim KH, Han SH, Cho YK, Kim KH, Hong SJ, Lee CJ, Na JO, Sung KC, Choi K, Kim SY, Kim DH, Lee HC, Ihm SH, Youn JC, Choi JY, Kim SH, Kim KI, Sung JH, Pyun WB, Kim WS, Cho JS, Lee Y, Her SH, Cho EJ, Lee EM, Lee HY, Yoon YW, Lee JH, Kim W, Rhee SJ, Shin J. Low-Dose Telmisartan/Amlodipine in Essential Hypertension: A Phase III Trial. J Clin Hypertens (Greenwich). 2026 May;28(5):e70279. doi: 10.1111/jch.70279.
- 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.
Jin Ho Shin, M.D., Ph.D principal investigator
Hanyang University
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-223A, AD-223B and AD-223C 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 2 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 4 Apr 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?
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?
On the ClinicalTrials.gov record for NCT06052748, 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 4 Apr 2025.