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

Ahn-Gook Pharmaceuticals Co.,Ltd306 enrolled

Overview

A phase 3 study to evaluate efficacy and safety of AGSAVI

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

306

Conditions

Hypertension

Interventions

AGSAVIDRUG

S-amlodipine, Valsartan, Indapamide

AGLSDRUG

S-amlodipine, Valsartan

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in sitSBP at week 10

Time frame: 10 weeks

Secondary Outcomes

Change from baseline in sitting diastolic blood pressure at week 4 and week 10

Time frame: week 4 and week 10

Change from baseline in sitting systolic blood pressure at week 4

Time frame: week 4

•Proportion of subjects achieving Blood Pressure control

Time frame: week 4 and week 10

Data from ClinicalTrials.gov

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