Hypertension,EssentialPhase 3NCT06348576
Phase III Study to Evaluate the Efficacy and Safety of AD-209
A Phase 3 study testing AD-209 and AD-2091 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-209 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-209 and AD-2091
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2024to Feb 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.
Chang Gyu Park, M.D., Ph.D contact
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Chang Gyu Park, M.D., Ph.D
Chang Gyu Park, M.D., Ph.D
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of AD-209
Read the detailed description
Condition or disease : hypertension
- Conditions
- Hypertension,Essential
- Being tested
- AD-209, AD-2091, AD-209 Placebo, AD-2091 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-209Drug
PO, Once daily(QD), 8weeks
AD-2091Drug
PO, Once daily(QD), 8weeks
AD-209 PlaceboDrug
PO, Once daily(QD), 8weeks
AD-2091 PlaceboDrug
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | AD-209+AD-2091 Placebo Receives: Drug: AD-209; Drug: AD-2091 Placebo |
| Control group | Active comparator | AD-2091+AD-209 Placebo Receives: Drug: AD-2091; Drug: AD-209 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 posted4 Apr 2024
- Study start20 May 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Gyu Park, M.D., Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348576
- Sponsor's protocol ID
- AD-209P3
- Status last verified
- May 2024
- First submitted
- 1 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahn JC, Lee CW, Ahn JH, Lim KH, Sohn IS, Sung KC, Kim KH, Bae JH, Hong SP, Jang WY, Jo SH, Han SH, Kim JB, Lee CJ, Lee JH, Kim N, Cho EJ, Sung JH, Ahn HS, Kim SY, Shin J, Seo SM, Hong SJ, Kim W, Park CG. Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT. Hypertension. 2026 Apr;83(4):e25810. doi: 10.1161/HYPERTENSIONAHA.125.25810. Epub 2026 Feb 20.
PubMed 41717679
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. 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-209 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06348576
- Acronym / sponsor ID
- AD-209P3
- Conditions
- Hypertension,Essential
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 4 Apr 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-209
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
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: AD-209, Drug: AD-2091 PlaceboAD-209+AD-2091 Placebo |
| Control group | Active comparator | Drug: AD-2091, Drug: AD-209 PlaceboAD-2091+AD-209 Placebo |
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-209PO, Once daily(QD), 8weeks | Drug | Test group |
| AD-2091PO, Once daily(QD), 8weeks | Drug | Control group |
| AD-209 PlaceboPO, Once daily(QD), 8weeks | Drug | Control group |
| AD-2091 PlaceboPO, Once daily(QD), 8weeks | Drug | 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41717679Ahn JC, Lee CW, Ahn JH, Lim KH, Sohn IS, Sung KC, Kim KH, Bae JH, Hong SP, Jang WY, Jo SH, Han SH, Kim JB, Lee CJ, Lee JH, Kim N, Cho EJ, Sung JH, Ahn HS, Kim SY, Shin J, Seo SM, Hong SJ, Kim W, Park CG. Low-Dose TEL/AML/CHTD SPC Versus Standard-Dose TEL in Hypertension: Phase III RCT. Hypertension. 2026 Apr;83(4):e25810. doi: 10.1161/HYPERTENSIONAHA.125.25810. Epub 2026 Feb 20.
- 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.
Chang Gyu Park, M.D., Ph.D contact
Chang Gyu Park, M.D., Ph.D principal investigator
Korea University Guro 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-209 and AD-2091 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: status not confirmed, as of the sponsor's last update on 21 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Tae Kim, D.V.M (82-031-891-5661, ktkim@addpharma.co.kr), or a site near the patient. 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 NCT06348576, 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 21 May 2024.