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

Ahn-Gook Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: AGSAVI; Drug: AGLS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05503953

AG-1705_P3

Details and patient eligibility

About

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

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 <= 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 2 patient groups

AGSAVI

Experimental group

Treatment:

Drug: AGSAVI

AGLS

Active Comparator group

Treatment:

Drug: AGLS