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

Hypertension,Essential Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218552
• Other study ID #: AD-209P2
• Status: Completed
• Phase: Phase 2
• Start date: February 25, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: January 2021
• Source: Addpharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Drug:
• AD209
PO, Once daily(QD), 8weeks
• Amlodipine low
PO, Once daily(QD), 8weeks
• Amlodipine high
PO, Once daily(QD), 8weeks
• Telmisartan
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	1. Change rate of MSSBP	Change from baseline in mean sitting systolic blood pressure	[ Time Frame: baseline, 8 weeks ]
Secondary	1. Change rate of MSSBP	Change from baseline in mean sitting systolic blood pressure	[ Time Frame: baseline, 4 weeks ]
Secondary	2. Change rate of MSDBP	Change from baseline in mean sitting diastolic blood pressure	[ Time Frame: baseline, 4 weeks, 8 weeks ]
Secondary	3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)	Proportion of subjects achieving blood pressure control	[ Time Frame: 4 weeks, 8 weeks ]
Secondary	4.Reaction rate of BP	Proportion of reduction from baseline in MSSBP/MSDBP = 20/10 mmHg	[ Time Frame: baseline, 4 weeks, 8 weeks ]