Phase III Study to Evaluate the Efficacy and Safety of AD-209

Phase 3

Recruiting

• Conditions: Hypertension,Essential
• Interventions: Drug: AD-209; Drug: AD-2091; Drug: AD-209 Placebo; Drug: AD-2091 Placebo

• Registration Number: NCT06348576
• 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

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Study Start: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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
Control group	AD-209 Placebo	AD-2091+AD-209 Placebo
Test group	AD-209	AD-209+AD-2091 Placebo
Test group	AD-2091 Placebo	AD-209+AD-2091 Placebo
Control group	AD-2091	AD-2091+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