Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension

Phase 2

Completed

• Conditions: Hypertension,Essential
• Interventions: Drug: Telmisartan; Drug: Amlodipine high; Drug: AD209; Drug: Amlodipine low

• Registration Number: NCT04218552
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.

Detailed Description

Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-02-25
• Status Verified: 2021-01
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Signed informed consent
• Other inclusions applied

Exclusion Criteria

• orthostatic hypotension with symptom
• Other exclusions applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator 3	Telmisartan	Telmisartan
Active Comparator 2	Amlodipine high	Amlodipine High
Placebo comparator	Amlodipine high	Placebo
Experimental 1	AD209	AD-209 High
Active Comparator 1	Amlodipine low	Amlodipine Low
Placebo comparator	Amlodipine low	Placebo
Experimental 3	AD209	AD-209 Low
Experimental 2	AD209	AD-209 Middle
Placebo comparator	AD209	Placebo
Placebo comparator	Telmisartan	Placebo

Primary Outcome Measures

Name	Time	Method
1. Change rate of MSSBP	[ Time Frame: baseline, 8 weeks ]	Change from baseline in mean sitting systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
1. Change rate of MSSBP	[ Time Frame: baseline, 4 weeks ]	Change from baseline in mean sitting systolic blood pressure
2. Change rate of MSDBP	[ Time Frame: baseline, 4 weeks, 8 weeks ]	Change from baseline in mean sitting diastolic blood pressure
4.Reaction rate of BP	[ Time Frame: baseline, 4 weeks, 8 weeks ]	Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg
3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)	[ Time Frame: 4 weeks, 8 weeks ]	Proportion of subjects achieving blood pressure control

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of