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

Sponsor
Addpharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04218552
Collaborator
(none)
176
Enrollment
1
Location
7
Arms
12
Actual Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 25, 2020
Actual Primary Completion Date :
Feb 25, 2021
Actual Study Completion Date :
Feb 25, 2021

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1. Change rate of MSSBP [[ Time Frame: baseline, 8 weeks ]]

      Change from baseline in mean sitting systolic blood pressure

    Secondary Outcome Measures

    1. 1. Change rate of MSSBP [[ Time Frame: baseline, 4 weeks ]]

      Change from baseline in mean sitting systolic blood pressure

    2. 2. Change rate of MSDBP [[ Time Frame: baseline, 4 weeks, 8 weeks ]]

      Change from baseline in mean sitting diastolic blood pressure

    3. 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

    4. 4.Reaction rate of BP [[ Time Frame: baseline, 4 weeks, 8 weeks ]]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed informed consent

    • Other inclusions applied

    Exclusion Criteria:

    • orthostatic hypotension with symptom

    • Other exclusions applied

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Guro Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Addpharma Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Addpharma Inc.
    ClinicalTrials.gov Identifier:
    NCT04218552
    Other Study ID Numbers:
    • AD-209P2
    First Posted:
    Jan 6, 2020
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Amlodipine
    Telmisartan

    Study Results

    No Results Posted as of Jul 21, 2021