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Clinical Trials/NCT06441630
NCT06441630
Recruiting
Phase 3

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension

Addpharma Inc.1 site in 1 country251 target enrollmentJuly 31, 2024

Overview

Phase
Phase 3
Intervention
AD-227C
Conditions
Essential Hypertension
Sponsor
Addpharma Inc.
Enrollment
251
Locations
1
Primary Endpoint
Change in MSSBP
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 31, 2024
End Date
September 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

Co-administration of AD-227A and AD-227C

AD-227A + Placebo of AD-227B + AD-227C

Intervention: AD-227C

Co-administration of AD-227A and AD-227C

AD-227A + Placebo of AD-227B + AD-227C

Intervention: Placebo of AD-227B

Co-administration of AD-227A and AD-227B

AD-227A + AD-227B + Placebo of AD-227C

Intervention: AD-227A

Co-administration of AD-227A and AD-227B

AD-227A + AD-227B + Placebo of AD-227C

Intervention: AD-227B

Co-administration of AD-227A and AD-227B

AD-227A + AD-227B + Placebo of AD-227C

Intervention: Placebo of AD-227C

AD-227A

AD-227A + Placebo of AD-227B + Placebo of AD-227C

Intervention: AD-227A

AD-227A

AD-227A + Placebo of AD-227B + Placebo of AD-227C

Intervention: Placebo of AD-227B

AD-227A

AD-227A + Placebo of AD-227B + Placebo of AD-227C

Intervention: Placebo of AD-227C

Co-administration of AD-227A and AD-227C

AD-227A + Placebo of AD-227B + AD-227C

Intervention: AD-227A

Outcomes

Primary Outcomes

Change in MSSBP

Time Frame: Baseline to Week8

Change from Baseline in Mean Sitting Systolic Blood Pressure

Study Sites (1)

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