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NCT06441630 Clinical Trial

A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B

Essential Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06441630
Other study ID # AD-227P3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 17, 2024
Est. completion date January 31, 2025

Study information
Verified date June 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 co-administration of AD-227A and AD-227B in patients with essential hypertension

Description:

Essential Hypertension

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 251
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
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-227A
Per Oral, 1 Tablet, Once a day for 8 weeks
• AD-227B
Per Oral, 1 Tablet, Once a day for 8 weeks
• AD-227C
Per Oral, 1 Tablet, Once a day for 8 weeks
• Placebo of AD-227B
Per Oral, 1 Tablet, Once a day for 8 weeks
• Placebo of AD-227C
Per Oral, 1 Tablet, Once a day for 8 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in MSSBP Change from Baseline in Mean Sitting Systolic Blood Pressure Baseline to Week8
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