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

August 16, 2022 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AGSAVI
Drug: AGSAVI
Uptitation
ACTIVE_COMPARATOR: AGLS
Drug: AGLS
Uptitration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From Baseline(Visit 2) to Visit 5(For 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators

Daehwa Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 5, 2022

Primary Completion (ANTICIPATED)

February 29, 2024

Study Completion (ANTICIPATED)

July 31, 2024

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (ACTUAL)

August 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG-1705_P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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