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This clinical trial is a randomized, active controlled, double blind, parallel, multi center, phase 3 study to evaluate the efficacy and safety of monotherapy group of HL1113R1 or HL1113R2 versus HL1113 (Fixed dose combination) in patients with essential hypertension and type II diabetes mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental |
| |
| Exploratory test group | Experimental |
| |
| Control group 1 | Placebo Comparator |
| |
| Control group 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test group | Drug | HL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) | Baseline, 12weeks | |
| Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1) | Baseline, 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) | Baseline, 12weeks | |
| Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang | Contact | 82234896198 | kyliekang@hanlim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Bucheon St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| Exploratory test group | Drug | HL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks |
|
| Control group 1 | Drug | HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks |
|
| Control group 2 | Drug | HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks |
|
| Baseline, 12weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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