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NCT06291207 Clinical Trial

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

Hypertension,Essential Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06291207
Other study ID # AD-224P3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 2024
Est. completion date December 2024

Study information
Verified date February 2024
Source Addpharma Inc.
Contact JeongEun Park
Phone +82-31-891-6989
Email parkje@addpharma.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Condition or disease : Essential Hypertension

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 252
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Patients with Essential Hypertension - Other inclusions applied Exclusion Criteria: - Patient with Secondary Hypertension - Other exclusions applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-224A
PO, Once daily, 8weeks
• AD-224B
PO, Once daily, 8weeks
• AD-224C
PO, Once daily, 8weeks
• Placebo of AD-224A
PO, Once daily, 8weeks
• Placebo of AD-224B
PO, Once daily, 8weeks
• Placebo of AD-224C
PO, Once daily, 8weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Change rate of MSSBP Change from baseline in mean sitting systolic blood pressure Baseline, Week 8
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