A Study to Evaluate the Efficacy and Safety of AD-209 | NCT05631990

Studies
A Study to Evaluate the Efficacy and Safety of AD-209

NCT05631990

Sponsor

Addpharma Inc.

Status

Completed

Last Update Posted

Apr 5, 2024Actual

Enrollment

221Actual

Phase

Phase 2

Conditions

Hypertension, Essential

Interventions

AD-209
AD-209-1A
AD-209-1B
AD-209-1C
AD-209 placebo
AD-209-1 placebo

Countries

South Korea

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2023Actual

Primary Completion Date

Nov 27, 2023Actual

Completion Date

Nov 27, 2023Actual

First Submitted Date

Nov 20, 2022

First Submission Date that Met QC Criteria

Nov 20, 2022

First Posted Date

Nov 30, 2022Actual

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

Apr 3, 2024

Last Update Posted Date

Apr 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-209

Detailed Description

Condition or disease : hypertension Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental 1	Experimental	AD-209, AD-209-1 placebo	Drug: AD-209 Drug: AD-209-1 placebo
Experimental 2	Experimental	AD-209-1A, AD-209 placebo	Drug: AD-209-1A Drug: AD-209 placebo
Experimental 3	Experimental	AD-209-1B, AD-209 placebo	Drug: AD-209-1B Drug: AD-209 placebo
Experimental 4	Experimental	AD-209-1C, AD-209 placebo	Drug: AD-209-1C Drug: AD-209 placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AD-209	Drug	PO, Once daily(QD), 8weeks	Experimental 1
AD-209-1A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change rate of MSSBP	Change from baseline in mean sitting systolic blood pressure	Baseline, Week 8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Other inclusions applied

Exclusion Criteria:

orthostatic hypotension with symptom
Other exclusions applied

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Gyu Park, M.D., Ph.D	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Seoul			South Korea

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

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided