A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B

Phase 3

Not yet recruiting

• Conditions: Essential Hypertension
• Interventions: Drug: AD-227A; Drug: AD-227B; Drug: AD-227C; Drug: Placebo of AD-227B; Drug: Placebo of AD-227C

• Registration Number: NCT06441630
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

Detailed Description

Essential Hypertension

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Study Start: 2024-09-17
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 251

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
Co-administration of AD-227A and AD-227B	Placebo of AD-227C	AD-227A + AD-227B + Placebo of AD-227C
AD-227A	AD-227A	AD-227A + Placebo of AD-227B + Placebo of AD-227C
Co-administration of AD-227A and AD-227C	AD-227A	AD-227A + Placebo of AD-227B + AD-227C
Co-administration of AD-227A and AD-227B	AD-227B	AD-227A + AD-227B + Placebo of AD-227C
Co-administration of AD-227A and AD-227C	AD-227C	AD-227A + Placebo of AD-227B + AD-227C
AD-227A	Placebo of AD-227B	AD-227A + Placebo of AD-227B + Placebo of AD-227C
Co-administration of AD-227A and AD-227B	AD-227A	AD-227A + AD-227B + Placebo of AD-227C
AD-227A	Placebo of AD-227C	AD-227A + Placebo of AD-227B + Placebo of AD-227C
Co-administration of AD-227A and AD-227C	Placebo of AD-227B	AD-227A + Placebo of AD-227B + AD-227C

Primary Outcome Measures

Name	Time	Method
Change in MSSBP	Baseline to Week8	Change from Baseline in Mean Sitting Systolic Blood Pressure