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

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Hypertension

Treatments: Drug: AGSAVI; Drug: AGLS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04686643

AGSAVI1705

Details and patient eligibility

About

A phase 3 study to evaluate efficacy and safety of AGSAVI

Full description

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

Enrollment: 306 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 2 patient groups

Treatment

Experimental group

Description:

AGSAVI

Treatment:

Drug: AGSAVI

Reference

Active Comparator group

Description:

AGLS

Treatment:

Drug: AGLS