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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AGSAVI
AGLS
Sponsored by
Ahn-Gook Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 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 <= 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment

    Reference

    Arm Description

    AGSAVI

    AGLS

    Outcomes

    Primary Outcome Measures

    Change from baseline in sitSBP at week 10

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 23, 2020
    Last Updated
    December 23, 2020
    Sponsor
    Ahn-Gook Pharmaceuticals Co.,Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04686643
    Brief Title
    Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension
    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
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    February 1, 2022 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ahn-Gook Pharmaceuticals Co.,Ltd

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    Treatment
    Arm Type
    Experimental
    Arm Description
    AGSAVI
    Arm Title
    Reference
    Arm Type
    Active Comparator
    Arm Description
    AGLS
    Intervention Type
    Drug
    Intervention Name(s)
    AGSAVI
    Other Intervention Name(s)
    S-amlodipine, Valsartan, Indapamide
    Intervention Description
    S-amlodipine, Valsartan, Indapamide
    Intervention Type
    Drug
    Intervention Name(s)
    AGLS
    Other Intervention Name(s)
    S-amlodipine, Valsartan
    Intervention Description
    S-amlodipine, Valsartan
    Primary Outcome Measure Information:
    Title
    Change from baseline in sitSBP at week 10
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline in sitting diastolic blood pressure at week 4 and week 10
    Time Frame
    week 4 and week 10
    Title
    Change from baseline in sitting systolic blood pressure at week 4
    Time Frame
    week 4
    Title
    •Proportion of subjects achieving Blood Pressure control
    Time Frame
    week 4 and week 10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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