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Completed

NCT Number: NCT05503953

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

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

Completed

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AhnGook

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 BP measuring at Visit 1
  • Patient with MSDBP >= 120mmHg at Visit 1 and 2
  • Patient with secondary hypertension(including past medical history)

Treatment and study plan

AGSAVI

Drug

Uptitation

AGLS

Drug

Uptitration

Primary outcomes

  1. Change of MSSBP(Mean Sitting Systolic Blood Pressure)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Collaborators

  • Daehwa Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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