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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