Hypertension, EssentialPhase 2NCT05631990
A Study to Evaluate the Efficacy and Safety of AD-209
A Phase 2 study testing AD-209, AD-209-1A and AD-209-1B 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 to 74 years
- Conditions the study is for
- Hypertension, Essential
- What is being tested?
- AD-209, AD-209-1A and AD-209-1B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2023to 27 Nov 2023
- Phase
- Phase 2
- 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 to 74 years
- 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 Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial 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 Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2
- Conditions
- Hypertension, Essential
- Being tested
- AD-209, AD-209-1A, AD-209-1B, AD-209-1C, AD-209 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-209-1ADrug
PO, Once daily(QD), 8weeks
AD-209-1BDrug
PO, Once daily(QD), 8weeks
AD-209-1CDrug
PO, Once daily(QD), 8weeks
AD-209 placeboDrug
PO, Once daily(QD), 8weeks
AD-209-1 placeboDrug
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | AD-209, AD-209-1 placebo Receives: Drug: AD-209; Drug: AD-209-1 placebo |
| Experimental 2 | Experimental | AD-209-1A, AD-209 placebo Receives: Drug: AD-209-1A; Drug: AD-209 placebo |
| Experimental 3 | Experimental | AD-209-1B, AD-209 placebo Receives: Drug: AD-209-1B; Drug: AD-209 placebo |
| Experimental 4 | Experimental | AD-209-1C, AD-209 placebo Receives: Drug: AD-209-1C; 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 posted30 Nov 2022
- Study start5 Apr 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
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
- NCT05631990
- Sponsor's protocol ID
- AD-209P2-02
- Status last verified
- Apr 2024
- First submitted
- 20 Nov 2022
- Last updated
- 5 Apr 2024
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT05631990
- Acronym / sponsor ID
- AD-209P2-02
- Conditions
- Hypertension, Essential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 30 Nov 2022 (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 Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: AD-209, Drug: AD-209-1 placeboAD-209, AD-209-1 placebo |
| Experimental 2 | Experimental | Drug: AD-209-1A, Drug: AD-209 placeboAD-209-1A, AD-209 placebo |
| Experimental 3 | Experimental | Drug: AD-209-1B, Drug: AD-209 placeboAD-209-1B, AD-209 placebo |
| Experimental 4 | Experimental | Drug: AD-209-1C, Drug: AD-209 placeboAD-209-1C, AD-209 placebo |
Who may qualify
- Ages
- 19 to 74 years
- 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 | Experimental 1 |
| AD-209-1APO, Once daily(QD), 8weeks | Drug | Experimental 2 |
| AD-209-1BPO, Once daily(QD), 8weeks | Drug | Experimental 3 |
| AD-209-1CPO, Once daily(QD), 8weeks | Drug | Experimental 4 |
| AD-209 placeboPO, Once daily(QD), 8weeks | Drug | Experimental 2, Experimental 3, Experimental 4 |
| AD-209-1 placeboPO, Once daily(QD), 8weeks | Drug | Experimental 1 |
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 5 Apr 2024.
- 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 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 2 study testing AD-209, AD-209-1A and AD-209-1B 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 5 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Apr 2024.