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A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | HCP1803 High |
|
| Experimental 2 | Experimental | HCP1803 Middle |
|
| Experimental 3 | Experimental | HCP1803 Low |
|
| Active Comparator 1 | Active Comparator | HGP0904 High |
|
| Active Comparator 2 | Active Comparator | HGP0904 Low |
|
| Active Comparator 3 | Active Comparator | HGP0608 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1803 | Drug | HCP1803 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting systolic blood pressure | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks | |
| Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moo-Yong Rhee, M.D., Ph.D. | Donggguk University Ilsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donggguk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 10326 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408462 | Derived | Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Comparator |
| Placebo Comparator |
Placebo |
|
| Amlodipine |
| Drug |
Amlodipine |
|
| Losartan | Drug | Losartan |
|
| Placebo | Drug | Placebo |
|
| Proportion of subjects achieving blood pressure control |
sitSBP/sitDBP < 140/90 mmHg |
| 4 weeks, 8 weeks |
| Proportion of responder | Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg | baseline, 4 weeks, 8 weeks |
| Change from baseline in pulse pressure(sitSBP - sitDBP) | baseline, 4 weeks, 8 weeks |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |