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

NCT ID: NCT04686643

Last Updated: 2020-12-29

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

2021-02-01

Study Completion Date

2022-05-01

Brief Summary

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A phase 3 study to evaluate efficacy and safety of AGSAVI

Detailed Description

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A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

Conditions

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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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Treatment

AGSAVI

Group Type EXPERIMENTAL

AGSAVI

Intervention Type DRUG

S-amlodipine, Valsartan, Indapamide

Reference

AGLS

Group Type ACTIVE_COMPARATOR

AGLS

Intervention Type DRUG

S-amlodipine, Valsartan

Interventions

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AGSAVI

S-amlodipine, Valsartan, Indapamide

Intervention Type DRUG

AGLS

S-amlodipine, Valsartan

Intervention Type DRUG

Other Intervention Names

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S-amlodipine, Valsartan, Indapamide S-amlodipine, Valsartan

Eligibility Criteria

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Inclusion Criteria

* Hypertension patient who satisfied below condition at Visit 1.

* patient who takes antihypertensive drug

* 140mmHg \<= sitSBP \<= 200mmHg
* patient who doesn't take antihypertensive drug

* 160mmHg \<= sitSBP \<= 200mmHg
* Hypertension patient who satisfied below condition at Visit 2.

* 140mmHg \<= sitSBP \<= 200mmHg at Visit 2
* 130mmHg \<= sitSBP \<= 200mmHg at Visit 2(In high-risk patients)

Exclusion Criteria

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 2 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 1 or 2
* Patient with secondary hypertension
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AGSAVI1705

Identifier Type: -

Identifier Source: org_study_id