NCT04686643

Brief Summary

A phase 3 study to evaluate efficacy and safety of AGSAVI

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 hypertension

Timeline
Completed

Started Feb 2021

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

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 23, 2020

Last Update Submit

December 23, 2020

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitSBP at week 10

    10 weeks

Secondary Outcomes (3)

  • Change from baseline in sitting diastolic blood pressure at week 4 and week 10

    week 4 and week 10

  • Change from baseline in sitting systolic blood pressure at week 4

    week 4

  • •Proportion of subjects achieving Blood Pressure control

    week 4 and week 10

Study Arms (2)

Treatment

EXPERIMENTAL

AGSAVI

Drug: AGSAVI

Reference

ACTIVE COMPARATOR

AGLS

Drug: AGLS

Interventions

AGSAVIDRUG

S-amlodipine, Valsartan, Indapamide

Also known as: S-amlodipine, Valsartan, Indapamide
Treatment
AGLSDRUG

S-amlodipine, Valsartan

Also known as: S-amlodipine, Valsartan
Reference

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipineValsartanIndapamide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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

December 23, 2020

First Posted

December 29, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share