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

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

Detailed Description
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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

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

Conditions
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Hypertension,Essential

Intervention / Treatment
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* Drug: AD209
* Drug: Amlodipine low
* Drug: Amlodipine high
* Drug: Telmisartan


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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Change rate of MSSBP | 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 | Change from baseline in mean sitting systolic blood pressure | [ Time Frame: baseline, 4 weeks ] | 
| 2. Change rate of MSDBP | 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) | Proportion of subjects achieving blood pressure control | [ Time Frame: 4 weeks, 8 weeks ] | 
| 4.Reaction rate of BP | Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg | [ Time Frame: baseline, 4 weeks, 8 weeks ] |