Back to resultsA Study to Evaluate the Efficacy and Safety of AD-209
Primary Purpose
Hypertension, Essential
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-209
AD-209-1A
AD-209-1B
AD-209-1C
AD-209 placebo
AD-209-1 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Essential
Eligibility Criteria
Inclusion Criteria: Signed informed consent Other inclusions applied Exclusion Criteria: orthostatic hypotension with symptom Other exclusions applied
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Experimental 1
Experimental 2
Experimental 3
Experimental 4
Arm Description
AD-209, AD-209-1 placebo
AD-209-1A, AD-209 placebo
AD-209-1B, AD-209 placebo
AD-209-1C, AD-209 placebo
Outcomes
Primary Outcome Measures
Change rate of MSSBP
Change from baseline in mean sitting systolic blood pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05631990
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-209
Official Title
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Essential
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
AD-209, AD-209-1 placebo
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
AD-209-1A, AD-209 placebo
Arm Title
Experimental 3
Arm Type
Experimental
Arm Description
AD-209-1B, AD-209 placebo
Arm Title
Experimental 4
Arm Type
Experimental
Arm Description
AD-209-1C, AD-209 placebo
Intervention Type
Drug
Intervention Name(s)
AD-209
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-209-1A
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-209-1B
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-209-1C
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-209 placebo
Intervention Description
PO, Once daily(QD), 8weeks
Intervention Type
Drug
Intervention Name(s)
AD-209-1 placebo
Intervention Description
PO, Once daily(QD), 8weeks
Primary Outcome Measure Information:
Title
Change rate of MSSBP
Description
Change from baseline in mean sitting systolic blood pressure
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Other inclusions applied
Exclusion Criteria:
orthostatic hypotension with symptom
Other exclusions applied
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Tae Kim, D.V.M
Phone
82-031-891-5661
Email
ktkim@addpharma.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Gyu Park, M.D., Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Gyu Park, M.D., Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of AD-209
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