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

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Collaborator: Daehwa Pharmaceutical Co., Ltd.

Criteria

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 between 2 times of BP measuring at Visit 1

• Patient with MSDBP >= 120mmHg at Visit 1 or 2

• Patient with secondary hypertension(including past medical history)