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The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients
This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | D064 and D702 Combination Therapy |
|
| Comparator Group 1 | Active Comparator | D064 Monotherapy |
|
| Comparator Group 2 | Active Comparator | D702 Monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D064 and D702, QD | Drug | Experimental Group Subjects assigned to this group are treated with D064, D702 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure)) | Compare experimental group with comparator group | 8 weeks |
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Inclusion Criteria:
Subjects who are 19 years old or older.
Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:
Didn't take antihypertensive drug
Taking antihypertensive drug
Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinho Shin, M.D, Ph.D | Hanyang University Seoul Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Seoul Hospital | Seoul | Seongdong-gu | 04763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41672793 | Derived | Lee SH, Park K, Lee KH, Cho Y, Kim DH, Lim S, Bo Yoon S, Jang JS, Lim HS, Doh JH, Kim DY, Sohn IS, Cheon DY, Bae MH, Kim SH, Lee Y, Ihm SH, Choi RK, Park HJ, Pyun WB, Choi S, Shin J. Efficacy and Safety of Combination Therapy With Low Dose of Telmisartan and S-Amlodipine in Patients With Hypertension: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial. Clin Ther. 2026 Mar;48(3):240-246. doi: 10.1016/j.clinthera.2026.01.001. Epub 2026 Feb 10. |
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| D064 and Placebo of D702, QD | Drug | Comparator Group Subjects assigned to this group are treated with D064, placebo of D702 |
|
|
| Placebo of D064 and D702, QD | Drug | Comparator Group Subjects assigned to this group are treated with D702, placebo of D064 |
|
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C482243 | 2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile |
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