Essential Hypertension
Conditions
Brief summary
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
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Daehwa Pharmaceutical 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 \<= MSSBP \< 200mmHg * 130mmHg \<= MSSBP \< 200mmHg at or before visit 1(In high-risk patients) * patient who doesn't take antihypertensive drug * 160mmHg \<= MSSBP \< 200mmHg * Hypertension patient who satisfied below condition at Visit 2. * 140mmHg \<= MSSBP \< 200mmHg at Visit 2 * 130mmHg \<= MSSBP \< 200mmHg at or before Visit 1(In high-risk patients)
Exclusion criteria
* Patient who have received 4 or more antihypertensive drug * Patient with 20mmHg\>= of difference in MSSBP or 10mmHg\>= of difference in MSDBP BP measuring at Visit 1 * Patient with MSDBP \>= 120mmHg at Visit 1 and 2 * Patient with secondary hypertension(including past medical history)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of MSSBP(Mean Sitting Systolic Blood Pressure) | From Baseline(Visit 2) to Visit 5(For 10 weeks) | Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks) |
Countries
South Korea
Outcome results
None listed