Phase III Study to Evaluate the Efficacy and Safety of AG... | NCT04686643

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

NCT04686643

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Status

Unknown status

Last Update Posted

Dec 29, 2020Actual

Enrollment

306Estimated

Phase

Phase 3

Conditions

Hypertension

Interventions

AGSAVI
AGLS

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Feb 1, 2022Estimated

Completion Date

May 1, 2022Estimated

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 23, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2020

Last Update Posted Date

Dec 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	AGSAVI	Drug: AGSAVI
Reference	Active Comparator	AGLS	Drug: AGLS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AGSAVI	Drug	S-amlodipine, Valsartan, Indapamide	Treatment	S-amlodipine, Valsartan, Indapamide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
C542574	levamlodipine
D000068756	Valsartan
D007190	Indapamide

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided