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

Primary Purpose

Hypertension,Essential

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AD209

Amlodipine low

Amlodipine high

Telmisartan

About this trial

This is an interventional treatment trial for Hypertension,Essential

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Other inclusions applied

Exclusion Criteria:

orthostatic hypotension with symptom
Other exclusions applied

Sites / Locations

Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental 1

Experimental 2

Experimental 3

Active Comparator 1

Active Comparator 2

Active Comparator 3

Placebo comparator

Arm Description

AD-209 High

AD-209 Middle

AD-209 Low

Amlodipine Low

Amlodipine High

Telmisartan

Placebo

Outcomes

Primary Outcome Measures

1. Change rate of MSSBP

Change from baseline in mean sitting systolic blood pressure

Secondary Outcome Measures

1. Change rate of MSSBP

Change from baseline in mean sitting systolic blood pressure

2. Change rate of MSDBP

Change from baseline in mean sitting diastolic blood pressure

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

4.Reaction rate of BP

Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg

Full Information

NCT ID

NCT04218552

First Posted

January 3, 2020

Last Updated

July 20, 2021

Sponsor

Addpharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04218552

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

February 25, 2020 (Actual)

Primary Completion Date

February 25, 2021 (Actual)

Study Completion Date

February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension,Essential

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental 1

Arm Type

Experimental

Arm Description

AD-209 High

Arm Title

Experimental 2

Arm Type

Experimental

Arm Description

AD-209 Middle

Arm Title

Experimental 3

Arm Type

Experimental

Arm Description

AD-209 Low

Arm Title

Active Comparator 1

Arm Type

Active Comparator

Arm Description

Amlodipine Low

Arm Title

Active Comparator 2

Arm Type

Active Comparator

Arm Description

Amlodipine High

Arm Title

Active Comparator 3

Arm Type

Active Comparator

Arm Description

Telmisartan

Arm Title

Placebo comparator

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

AD209

Other Intervention Name(s)

AD209 Placebo

Intervention Description

PO, Once daily(QD), 8weeks

Intervention Type

Drug

Intervention Name(s)

Amlodipine low

Other Intervention Name(s)

Amlodipine low placebo

Intervention Description

PO, Once daily(QD), 8weeks

Intervention Type

Drug

Intervention Name(s)

Amlodipine high

Other Intervention Name(s)

Amlodipine high placebo

Intervention Description

PO, Once daily(QD), 8weeks

Intervention Type

Drug

Intervention Name(s)

Telmisartan

Other Intervention Name(s)

Telmisartan placebo

Intervention Description

PO, Once daily(QD), 8weeks

Primary Outcome Measure Information:

Title

1. Change rate of MSSBP

Description

Change from baseline in mean sitting systolic blood pressure

Time Frame

[ Time Frame: baseline, 8 weeks ]

Secondary Outcome Measure Information:

Title

1. Change rate of MSSBP

Description

Change from baseline in mean sitting systolic blood pressure

Time Frame

[ Time Frame: baseline, 4 weeks ]

Title

2. Change rate of MSDBP

Description

Change from baseline in mean sitting diastolic blood pressure

Time Frame

[ Time Frame: baseline, 4 weeks, 8 weeks ]

Title

3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)

Description

Proportion of subjects achieving blood pressure control

Time Frame

[ Time Frame: 4 weeks, 8 weeks ]

Title

4.Reaction rate of BP

Description

Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg

Time Frame

[ Time Frame: baseline, 4 weeks, 8 weeks ]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Other inclusions applied Exclusion Criteria: orthostatic hypotension with symptom Other exclusions applied

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ChangGu Park, M.D., Ph.D

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36094783

Citation

Sung KC, Sung JH, Cho EJ, Ahn JC, Han SH, Kim W, Kim KH, Sohn IS, Shin J, Kim SY, Kim KI, Kang SM, Park SJ, Kim YJ, Shin JH, Park SM, Park CG. Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1298-1309. doi: 10.1111/jch.14570. Epub 2022 Sep 12.

Results Reference

derived

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

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