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

Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05503953
Collaborator
Daehwa Pharmaceutical Co., Ltd. (Industry)
306
Enrollment
2
Arms
22.8
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 5, 2022
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AGSAVI

Drug: AGSAVI
Uptitation
Active Comparator: AGLS

Drug: AGLS
Uptitration

Outcome Measures

Primary Outcome Measures

  1. Change of MSSBP(Mean Sitting Systolic Blood Pressure) [From Baseline(Visit 2) to Visit 5(For 10 weeks)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ahn-Gook Pharmaceuticals Co.,Ltd
  • Daehwa Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05503953
Other Study ID Numbers:
  • AG-1705_P3
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension
Essential Hypertension

Study Results

No Results Posted as of Aug 18, 2022