NCT05503953

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

August 15, 2022

Last Update Submit

August 16, 2022

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change of MSSBP(Mean Sitting Systolic Blood Pressure)

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

    From Baseline(Visit 2) to Visit 5(For 10 weeks)

Study Arms (2)

AGSAVI

EXPERIMENTAL
Drug: AGSAVI

AGLS

ACTIVE COMPARATOR
Drug: AGLS

Interventions

AGSAVIDRUG

Uptitation

AGSAVI
AGLSDRUG

Uptitration

AGLS

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension patient who satisfied below condition at Visit 1.
  • patient who takes antihypertensive drug
  • mmHg \<= MSSBP \< 200mmHg
  • mmHg \<= MSSBP \< 200mmHg at or before visit 1(In high-risk patients)
  • patient who doesn't take antihypertensive drug
  • mmHg \<= MSSBP \< 200mmHg
  • Hypertension patient who satisfied below condition at Visit 2.
  • mmHg \<= MSSBP \< 200mmHg at Visit 2
  • mmHg \<= MSSBP \< 200mmHg at or before Visit 1(In high-risk patients)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

September 5, 2022

Primary Completion

February 29, 2024

Study Completion

July 31, 2024

Last Updated

August 18, 2022

Record last verified: 2022-08