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

July 20, 2021 updated by: Addpharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Other inclusions applied

Exclusion Criteria:

  • orthostatic hypotension with symptom
  • Other exclusions applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo comparator
Placebo
Drug: AD209
PO, Once daily(QD), 8weeks
Other Names:
  • AD209 Placebo
Drug: Amlodipine low
PO, Once daily(QD), 8weeks
Other Names:
  • Amlodipine low placebo
Drug: Amlodipine high
PO, Once daily(QD), 8weeks
Other Names:
  • Amlodipine high placebo
Drug: Telmisartan
PO, Once daily(QD), 8weeks
Other Names:
  • Telmisartan placebo
Experimental: Experimental 1
AD-209 High
Drug: AD209
PO, Once daily(QD), 8weeks
Other Names:
  • AD209 Placebo
Experimental: Experimental 2
AD-209 Middle
Drug: AD209
PO, Once daily(QD), 8weeks
Other Names:
  • AD209 Placebo
Experimental: Experimental 3
AD-209 Low
Drug: AD209
PO, Once daily(QD), 8weeks
Other Names:
  • AD209 Placebo
Active Comparator: Active Comparator 1
Amlodipine Low
Drug: Amlodipine low
PO, Once daily(QD), 8weeks
Other Names:
  • Amlodipine low placebo
Active Comparator: Active Comparator 2
Amlodipine High
Drug: Amlodipine high
PO, Once daily(QD), 8weeks
Other Names:
  • Amlodipine high placebo
Active Comparator: Active Comparator 3
Telmisartan
Drug: Telmisartan
PO, Once daily(QD), 8weeks
Other Names:
  • Telmisartan placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: ChangGu Park, M.D., Ph.D, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2020

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-209P2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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