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

Phase 3

• Conditions: Essential Hypertension
• Interventions: Drug: AGSAVI; Drug: AGLS

• Registration Number: NCT05503953
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-18
• Study Start: 2022-09-05
• Primary Completion: 2024-02-29
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGSAVI	AGSAVI	-
AGLS	AGLS	-

Primary Outcome Measures

Name	Time	Method
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)