Essential HypertensionPhase 3NCT05503953
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
A Phase 3 study testing AGSAVI and AGLS in people with Essential Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS 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?
- AGSAVI and AGLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2022to 10 Jun 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
- Hypertension patient who satisfied below condition at Visit 1.
- patient who takes antihypertensive drug
- 140mmHg <= MSSBP < 200mmHg
- 130mmHg <= MSSBP < 200mmHg at or before visit 1(In high-risk patients)
- patient who doesn't take antihypertensive drug
- 160mmHg <= MSSBP < 200mmHg
Show all 9Show fewer
- Hypertension patient who satisfied below condition at Visit 2.
- 140mmHg <= MSSBP < 200mmHg at Visit 2
- 130mmHg <= MSSBP < 200mmHg at or before Visit 1(In high-risk patients)
Who cannot join
- Patient who have received 4 or more antihypertensive drug
- Patient with 20mmHg>= of difference in MSSBP or 10mmHg>= of difference in MSDBP BP measuring at Visit 1
- Patient with MSDBP >= 120mmHg at Visit 1 and 2
- Patient with secondary hypertension(including past medical history)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS
- Conditions
- Essential Hypertension
- Being tested
- AGSAVI, AGLS
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGSAVIDrug
Uptitation
AGLSDrug
Uptitration
| Study group | Role | What they receive |
|---|---|---|
| AGSAVI | Experimental | Not described Receives: Drug: AGSAVI |
| AGLS | Active comparator | Not described Receives: Drug: AGLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MSSBP(Mean Sitting Systolic Blood Pressure)
Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks)
Measured: From Baseline(Visit 2) to Visit 5(For 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start13 Sep 2022
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
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.
- 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
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daehwa Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503953
- Sponsor's protocol ID
- AG-1705_P3
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. 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 AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
- ClinicalTrials.gov ID
- NCT05503953
- Acronym / sponsor ID
- AG-1705_P3
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Daehwa Pharmaceutical Co., Ltd.
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 17 Aug 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.
A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGSAVI | Experimental | Drug: AGSAVI |
| AGLS | Active comparator | Drug: AGLS |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hypertension patient who satisfied below condition at Visit 1.
- Hypertension patient who satisfied below condition at Visit 2.
Key exclusion criteria (4 listed)
- Patient who have received 4 or more antihypertensive drug
- Patient with 20mmHg>= of difference in MSSBP or 10mmHg>= of difference in MSDBP BP measuring at Visit 1
- Patient with MSDBP >= 120mmHg at Visit 1 and 2
- Patient with secondary hypertension(including past medical history)
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 |
|---|---|---|
| AGSAVIUptitation | Drug | AGSAVI |
| AGLSUptitration | Drug | AGLS |
Primary outcome
Change of MSSBP(Mean Sitting Systolic Blood Pressure)
Time frame: From Baseline(Visit 2) to Visit 5(For 10 weeks)
Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks)
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 10 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AGSAVI and AGLS in people with Essential Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd 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 9 inclusion and 4 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 10 Sep 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 of MSSBP(Mean Sitting Systolic Blood Pressure) (time frame: From Baseline(Visit 2) to Visit 5(For 10 weeks)). 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 10 Sep 2026.