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Clinical Trials/NCT06291207
NCT06291207
Recruiting
Phase 3

A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients with Essential Hypertension

Addpharma Inc.1 site in 1 country252 target enrollmentApril 15, 2024

Overview

Phase
Phase 3
Intervention
AD-224B
Conditions
Hypertension,Essential
Sponsor
Addpharma Inc.
Enrollment
252
Locations
1
Primary Endpoint
Change rate of MSSBP
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

Condition or disease : Essential Hypertension

Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
July 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patient with Secondary Hypertension
  • Other exclusions applied

Arms & Interventions

AD-224B

Placebo of AD-224A+AD-224B+Placebo of AD-224C

Intervention: AD-224B

AD-224B

Placebo of AD-224A+AD-224B+Placebo of AD-224C

Intervention: Placebo of AD-224A

AD-224B

Placebo of AD-224A+AD-224B+Placebo of AD-224C

Intervention: Placebo of AD-224C

AD-224C

Placebo of AD-224A+Placebo of AD-224B+AD-224C

Intervention: AD-224C

AD-224C

Placebo of AD-224A+Placebo of AD-224B+AD-224C

Intervention: Placebo of AD-224A

AD-224C

Placebo of AD-224A+Placebo of AD-224B+AD-224C

Intervention: Placebo of AD-224B

AD-224A

AD-224A+Placebo of AD-224B+Placebo of AD-224C

Intervention: AD-224A

AD-224A

AD-224A+Placebo of AD-224B+Placebo of AD-224C

Intervention: Placebo of AD-224B

AD-224A

AD-224A+Placebo of AD-224B+Placebo of AD-224C

Intervention: Placebo of AD-224C

Outcomes

Primary Outcomes

Change rate of MSSBP

Time Frame: Baseline, Week 8

Change from baseline in mean sitting systolic blood pressure

Study Sites (1)

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