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Status unknownNCT04686643Updated Dec 29, 2020

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

A Phase 3 interventional study of AGSAVI and AGLS in Hypertension, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-12-29.

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

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

A phase 3 study to evaluate efficacy and safety of AGSAVI

Read the detailed description

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

02

Conditions studied

  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's planned enrollment of 306 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 23 studies on the registry; 4 are open to participants now.

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

Inclusion criteria

  • Hypertension patient who satisfied below condition at Visit 1.

    • patient who takes antihypertensive drug

      • 140mmHg \<= sitSBP \<= 200mmHg

    • patient who doesn't take antihypertensive drug

      • 160mmHg \<= sitSBP \<= 200mmHg

  • Hypertension patient who satisfied below condition at Visit 2.

    • 140mmHg \<= sitSBP \<= 200mmHg at Visit 2
    • 130mmHg \<= sitSBP \<= 200mmHg at Visit 2(In high-risk patients)

Exclusion criteria

Exclusion Criteria:

  • Patient who have received 4 or more antihypertensive drug
  • Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 2 times of BP measuring at Visit 1
  • Patient with sitDBP >= 120mmHg at Visit 1 or 2
  • Patient with secondary hypertension
05

Study design

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

Study arms

  • Experimental
    Treatment

    AGSAVI

    Drug: AGSAVI

  • Active comparator
    Reference

    AGLS

    Drug: AGLS

Interventions

  • DrugAGSAVI

    S-amlodipine, Valsartan, Indapamide

    Also known as: S-amlodipine, Valsartan, Indapamide

  • DrugAGLS

    S-amlodipine, Valsartan

    Also known as: S-amlodipine, Valsartan

06

What researchers measure

Primary outcomes

  1. Change from baseline in sitSBP at week 10

    Time frame: 10 weeks

Secondary outcomes

  1. Change from baseline in sitting diastolic blood pressure at week 4 and week 10

    Time frame: week 4 and week 10

  2. Change from baseline in sitting systolic blood pressure at week 4

    Time frame: week 4

  3. •Proportion of subjects achieving Blood Pressure control

    Time frame: week 4 and week 10

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04686643
Lead sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Dec 29, 2020
Start date
Feb 1, 2021 (estimated)
Primary completion
Feb 1, 2022 (estimated)
Completion
May 1, 2022 (estimated)
Last update
Dec 29, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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