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

Primary Purpose

Essential Hypertension

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

AGSAVI

AGLS

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AGSAVI

AGLS

Arm Description

Outcomes

Primary Outcome Measures

Change of MSSBP(Mean Sitting Systolic Blood Pressure)

Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks)

Secondary Outcome Measures

Full Information

NCT ID

NCT05503953

First Posted

August 15, 2022

Last Updated

August 16, 2022

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators

Daehwa Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05503953

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 5, 2022 (Anticipated)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators

Daehwa Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AGSAVI

Arm Type

Experimental

Arm Title

AGLS

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

AGSAVI

Intervention Description

Uptitation

Intervention Type

Drug

Intervention Name(s)

AGLS

Intervention Description

Uptitration

Primary Outcome Measure Information:

Title

Change of MSSBP(Mean Sitting Systolic Blood Pressure)

Description

Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks)

Time Frame

From Baseline(Visit 2) to Visit 5(For 10 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

12. IPD Sharing Statement

Learn more about this trial

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

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