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

December 23, 2020 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 phase 3 study to evaluate efficacy and safety of AGSAVI

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

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 <= 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

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: Treatment
AGSAVI
Drug: AGSAVI
S-amlodipine, Valsartan, Indapamide
Other Names:
  • S-amlodipine, Valsartan, Indapamide
ACTIVE_COMPARATOR: Reference
AGLS
Drug: AGLS
S-amlodipine, Valsartan
Other Names:
  • S-amlodipine, Valsartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in sitSBP at week 10
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in sitting diastolic blood pressure at week 4 and week 10
Time Frame: week 4 and week 10
week 4 and week 10
Change from baseline in sitting systolic blood pressure at week 4
Time Frame: week 4
week 4
•Proportion of subjects achieving Blood Pressure control
Time Frame: week 4 and week 10
week 4 and week 10

Collaborators and Investigators

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

Sponsor

Ahn-Gook Pharmaceuticals 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)

February 1, 2021

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (ACTUAL)

December 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGSAVI1705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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