Essential HypertensionPhase 3NCT06441630
A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B
A Phase 3 study testing AD-227A, AD-227B and AD-227C in people with Essential Hypertension, 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 co-administration of AD-227A and AD-227B in patients with essential hypertension Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- AD-227A, AD-227B and AD-227C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2024to Sep 2025
- 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
- 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. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam CHA Medical Center
Seoul
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension
Read the detailed description
Essential Hypertension
- Conditions
- Essential Hypertension
- Being tested
- AD-227A, AD-227B, AD-227C, Placebo of AD-227B, Placebo of AD-227C
- 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-227ADrug
Per Oral, 1 Tablet, Once a day for 8 weeks
AD-227BDrug
Per Oral, 1 Tablet, Once a day for 8 weeks
AD-227CDrug
Per Oral, 1 Tablet, Once a day for 8 weeks
Placebo of AD-227BDrug
Per Oral, 1 Tablet, Once a day for 8 weeks
Placebo of AD-227CDrug
Per Oral, 1 Tablet, Once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Co-administration of AD-227A and AD-227B | Experimental | AD-227A + AD-227B + Placebo of AD-227C Receives: Drug: AD-227A; Drug: AD-227B; Drug: Placebo of AD-227C |
| AD-227A | Active comparator | AD-227A + Placebo of AD-227B + Placebo of AD-227C Receives: Drug: AD-227A; Drug: Placebo of AD-227B; Drug: Placebo of AD-227C |
| Co-administration of AD-227A and AD-227C | Active comparator | AD-227A + Placebo of AD-227B + AD-227C Receives: Drug: AD-227A; Drug: AD-227C; Drug: Placebo of AD-227B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MSSBP
Change from Baseline in Mean Sitting Systolic Blood Pressure
Measured: Baseline to Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start31 Jul 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- 251 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chong-Jin Kim, Principal investigator, Gangnam CHA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441630
- Sponsor's protocol ID
- AD-227P3
- Status last verified
- Feb 2025
- First submitted
- 29 May 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension
- ClinicalTrials.gov ID
- NCT06441630
- Acronym / sponsor ID
- AD-227P3
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 251 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 Jun 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 co-administration of AD-227A and AD-227B in patients with essential hypertension
Detailed description
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 |
|---|---|---|
| Co-administration of AD-227A and AD-227B | Experimental | Drug: AD-227A, Drug: AD-227B, Drug: Placebo of AD-227CAD-227A + AD-227B + Placebo of AD-227C |
| AD-227A | Active comparator | Drug: AD-227A, Drug: Placebo of AD-227B, Drug: Placebo of AD-227CAD-227A + Placebo of AD-227B + Placebo of AD-227C |
| Co-administration of AD-227A and AD-227C | Active comparator | Drug: AD-227A, Drug: AD-227C, Drug: Placebo of AD-227BAD-227A + Placebo of AD-227B + AD-227C |
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-227APer Oral, 1 Tablet, Once a day for 8 weeks | Drug | AD-227A, Co-administration of AD-227A and AD-227B, Co-administration of AD-227A and AD-227C |
| AD-227BPer Oral, 1 Tablet, Once a day for 8 weeks | Drug | Co-administration of AD-227A and AD-227B |
| AD-227CPer Oral, 1 Tablet, Once a day for 8 weeks | Drug | Co-administration of AD-227A and AD-227C |
| Placebo of AD-227BPer Oral, 1 Tablet, Once a day for 8 weeks | Drug | AD-227A, Co-administration of AD-227A and AD-227C |
| Placebo of AD-227CPer Oral, 1 Tablet, Once a day for 8 weeks | Drug | AD-227A, Co-administration of AD-227A and AD-227B |
Primary outcome
Change in MSSBP
Time frame: Baseline to Week8
Change from Baseline in Mean Sitting Systolic Blood Pressure
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 4 Feb 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.
Chong-Jin Kim principal investigator
Gangnam CHA Medical Center
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-227A, AD-227B and AD-227C in people with Essential Hypertension, 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: looking for participants now, as of the sponsor's last update on 4 Feb 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 JeongEun Park (+82-31-891-6989, parkje@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MSSBP (time frame: Baseline to Week8). 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 4 Feb 2025.