Status:

UNKNOWN

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

Lead Sponsor:

Ahn-Gook Pharmaceuticals Co.,Ltd

Conditions:

Hypertension

Eligibility:

All Genders

19+ years

Phase:

PHASE3

Brief 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 Criteria

Inclusion

  • 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

  • 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 Trial Info

Start Date :

February 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2022

Estimated Enrollment :

306 Patients enrolled

Trial Details

Trial ID

NCT04686643

Start Date

February 1 2021

End Date

May 1 2022

Last Update

December 29 2020

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