A Study to Evaluate the Efficacy and Safety of AD-224

Phase 3

Recruiting

• Conditions: Hypertension,Essential
• Interventions: Drug: AD-224A; Drug: AD-224B; Drug: AD-224C; Drug: Placebo of AD-224B; Drug: Placebo of AD-224A; Drug: Placebo of AD-224C

• Registration Number: NCT06291207
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-224

Detailed Description

Condition or disease : Essential Hypertension

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-04
• Study Start: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Signed informed consent
• Patients with Essential Hypertension
• Other inclusions applied

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Exclusion Criteria

• Patient with Secondary Hypertension
• Other exclusions applied

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-224A	AD-224A	AD-224A+Placebo of AD-224B+Placebo of AD-224C
AD-224A	Placebo of AD-224B	AD-224A+Placebo of AD-224B+Placebo of AD-224C
AD-224B	Placebo of AD-224A	Placebo of AD-224A+AD-224B+Placebo of AD-224C
AD-224B	AD-224B	Placebo of AD-224A+AD-224B+Placebo of AD-224C
AD-224A	Placebo of AD-224C	AD-224A+Placebo of AD-224B+Placebo of AD-224C
AD-224B	Placebo of AD-224C	Placebo of AD-224A+AD-224B+Placebo of AD-224C
AD-224C	Placebo of AD-224A	Placebo of AD-224A+Placebo of AD-224B+AD-224C
AD-224C	AD-224C	Placebo of AD-224A+Placebo of AD-224B+AD-224C
AD-224C	Placebo of AD-224B	Placebo of AD-224A+Placebo of AD-224B+AD-224C

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)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of