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NCT05631990 Clinical Trial

A Study to Evaluate the Efficacy and Safety of AD-209

Hypertension, Essential Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05631990
Other study ID # AD-209P2-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 5, 2023
Est. completion date November 27, 2023

Study information
Verified date April 2024
Source Addpharma Inc.
Contact n/a
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 Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2

Recruitment information / eligibility
Status Completed
Enrollment 221
Est. completion date November 27, 2023
Est. primary completion date November 27, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 74 Years
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-209-1A
PO, Once daily(QD), 8weeks
• AD-209-1B
PO, Once daily(QD), 8weeks
• AD-209-1C
PO, Once daily(QD), 8weeks
• AD-209 placebo
PO, Once daily(QD), 8weeks
• AD-209-1 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
See also
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Completed NCT02466490 - Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension Phase 3
Completed NCT01303783 - Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension Phase 2
Completed NCT01350609 - Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed Phase 1
Not yet recruiting NCT04332562 - The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension N/A