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CompletedNCT05503953Updated Sep 10, 2026

Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

A Phase 3 interventional study of AGSAVI and AGLS in Essential Hypertension, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Essential Hypertension
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's enrollment of 318 is above the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Browse Ahn-Gook Pharmaceuticals Co.,Ltd studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    AGSAVI

    Drug: AGSAVI

  • Active comparator
    AGLS

    Drug: AGLS

Interventions

  • DrugAGSAVI

    Uptitation

  • DrugAGLS

    Uptitration

06

What researchers measure

Primary outcomes

  1. Change of MSSBP(Mean Sitting Systolic Blood Pressure)

    Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks)

    Time frame: From Baseline(Visit 2) to Visit 5(For 10 weeks)

07

Study locations

1 site
  • AhnGook
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Jun 2025, 32 months.

Of 45 industry-sponsored phase 3 interventional studies under Essential Hypertension, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 24. This study's 32 months is above that.

Counting every sponsor, half of 47 studies reached it within 17 months; a quarter within 11 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2022
First posted
Aug 17, 2022
StartActual
Sep 13, 2022
Primary completionActual
Jun 10, 2025
CompletionActual
Jun 10, 2025
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05503953
Lead sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators
Daehwa Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 17, 2022
Start date
Sep 13, 2022
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025
Last update
Sep 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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