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The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | AD-209 High |
|
| Experimental 2 | Experimental | AD-209 Middle |
|
| Experimental 3 | Experimental | AD-209 Low |
|
| Active Comparator 1 | Active Comparator | Amlodipine Low |
|
| Active Comparator 2 | Active Comparator | Amlodipine High |
|
| Active Comparator 3 | Active Comparator | Telmisartan |
|
| Placebo comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD209 | Drug | PO, Once daily(QD), 8weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change rate of MSSBP | Change from baseline in mean sitting systolic blood pressure | [ Time Frame: baseline, 8 weeks ] |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ChangGu Park, M.D., Ph.D | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094783 | Derived | 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. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Placebo |
|
| Amlodipine low | Drug | PO, Once daily(QD), 8weeks |
|
|
| Amlodipine high | Drug | PO, Once daily(QD), 8weeks |
|
|
| Telmisartan | Drug | PO, Once daily(QD), 8weeks |
|
|
| [ 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 ] |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |