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OpenTrials
Completed

NCT Number: NCT04218552

Determining 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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Other inclusions applied

Exclusion criteria

  • orthostatic hypotension with symptom
  • Other exclusions applied

Treatment and study plan

AD209

Drug

PO, Once daily(QD), 8weeks

Other names: AD209 Placebo

Amlodipine low

Drug

PO, Once daily(QD), 8weeks

Other names: Amlodipine low placebo

Amlodipine high

Drug

PO, Once daily(QD), 8weeks

Other names: Amlodipine high placebo

Telmisartan

Drug

PO, Once daily(QD), 8weeks

Other names: Telmisartan placebo

Primary outcomes

  1. 1. Change rate of MSSBP

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

    Change from baseline in mean sitting systolic blood pressure

Secondary outcomes

  1. 1. Change rate of MSSBP

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

    Change from baseline in mean sitting systolic blood pressure

  2. 2. Change rate of MSDBP

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

    Proportion of subjects achieving blood pressure control

  4. 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

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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