Hypertension
Conditions
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
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sitSBP at week 10 | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed