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

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 3 study to evaluate efficacy and safety of AGSAVI

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Treatments: Amlodipine; Indapamide; Niacin; Valsartan

Criteria

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