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UNKNOWNPHASE3

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

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

NCT04686643•Ahn-Gook Pharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

Summary

A phase 3 study to evaluate efficacy and safety of AGSAVI

Detailed Description

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

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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

•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

Key Dates

Start Date

February 1, 2021

Primary Completion Date

February 1, 2022

Completion Date

May 1, 2022

Last Updated

December 29, 2020

Enrollment

306

ESTIMATED participants

Conditions

Hypertension

Interventions

AGSAVI

DRUG

AGLS

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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