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NCT06348576 Clinical Trial

Phase III Study to Evaluate the Efficacy and Safety of AD-209

Hypertension,Essential Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06348576
Other study ID # AD-209P3
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 20, 2024
Est. completion date February 2025

Study information
Verified date May 2024
Source Addpharma Inc.
Contact Kyung Tae Kim, D.V.M
Phone 82-031-891-5661
Email ktkim@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-209

Description:

Condition or disease : hypertension

Recruitment information / eligibility
Status Recruiting
Enrollment 280
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Other inclusions applied Exclusion Criteria: - Orthostatic hypotension with symptom - Other exclusions applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-209
PO, Once daily(QD), 8weeks
• AD-2091
PO, Once daily(QD), 8weeks
• AD-209 Placebo
PO, Once daily(QD), 8weeks
• AD-2091 Placebo
PO, Once daily(QD), 8weeks

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

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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