A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-223A and AD-223B Combination Therapy in Patients With Essential Hypertension
Overview
- Phase
- Phase 3
- Intervention
- AD-223A
- Conditions
- Hypertension,Essential
- Sponsor
- Addpharma Inc.
- Enrollment
- 502
- Locations
- 1
- Primary Endpoint
- Change rate of MSSBP
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of AD-223
Detailed Description
Condition or disease : hypertension
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Other inclusions applied
Exclusion Criteria
- •Orthostatic hypotension with symptom
- •Other exclusions applied
Arms & Interventions
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
Intervention: AD-223A
Test group
AD-223A+AD-223B+AD-223C Placebo
Intervention: AD-223A
Test group
AD-223A+AD-223B+AD-223C Placebo
Intervention: AD-223B
Test group
AD-223A+AD-223B+AD-223C Placebo
Intervention: AD-223C Placebo
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
Intervention: AD-223B Placebo
Control group 1
AD-223A+AD-223B Placebo+AD-223C Placebo
Intervention: AD-223C Placebo
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
Intervention: AD-223B Placebo
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
Intervention: AD-223B
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
Intervention: AD-223A Placebo
Control group 2
AD-223A Placebo+AD-223B+AD-223C Placebo
Intervention: AD-223C Placebo
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
Intervention: AD-223C
Control group 3
AD-223A Placebo+AD-223B Placebo+AD-223C
Intervention: AD-223A Placebo
Outcomes
Primary Outcomes
Change rate of MSSBP
Time Frame: Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure