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

Phase 2

Completed

• Conditions: Hypertension, Essential
• Interventions: Drug: AD-209-1C; Drug: AD-209-1B; Drug: AD-209; Drug: AD-209-1A; Drug: AD-209-1 placebo; Drug: AD-209 placebo

• Registration Number: NCT05631990
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Study Start: 2023-04-05
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Signed informed consent
• Other inclusions applied

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Exclusion Criteria

• orthostatic hypotension with symptom
• Other exclusions applied

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 1	AD-209-1 placebo	AD-209, AD-209-1 placebo
Experimental 2	AD-209 placebo	AD-209-1A, AD-209 placebo
Experimental 3	AD-209 placebo	AD-209-1B, AD-209 placebo
Experimental 4	AD-209-1C	AD-209-1C, AD-209 placebo
Experimental 3	AD-209-1B	AD-209-1B, AD-209 placebo
Experimental 4	AD-209 placebo	AD-209-1C, AD-209 placebo
Experimental 1	AD-209	AD-209, AD-209-1 placebo
Experimental 2	AD-209-1A	AD-209-1A, AD-209 placebo

Primary Outcome Measures

Name	Time	Method
Change rate of MSSBP	Baseline, Week 8	Change from baseline in mean sitting systolic blood pressure

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of