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

NCT ID: NCT05503953

Last Updated: 2022-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGSAVI

Group Type EXPERIMENTAL

AGSAVI

Intervention Type DRUG

Uptitation

AGLS

Group Type ACTIVE_COMPARATOR

AGLS

Intervention Type DRUG

Uptitration

Interventions

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AGSAVI

Uptitation

Intervention Type DRUG

AGLS

Uptitration

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daehwa Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AG-1705_P3

Identifier Type: -

Identifier Source: org_study_id

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