Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension
- Registration Number
- NCT04686643
- Lead Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 306
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment AGSAVI AGSAVI Reference AGLS AGLS
- Primary Outcome Measures
Name Time Method Change from baseline in sitSBP at week 10 10 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in sitting diastolic blood pressure at week 4 and week 10 week 4 and week 10 Change from baseline in sitting systolic blood pressure at week 4 week 4 •Proportion of subjects achieving Blood Pressure control week 4 and week 10