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Strategy review
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The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atenas association | Experimental | The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Atenas, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan + amlodipine placebo, oral. |
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| Empagliflozin + telmisartan + amlodipine | Active Comparator | The patient must take 3 tablets once a day, as follows: 1 tablet Atenas placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan + amlodipine, oral. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atenas | Drug | ATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Changes from baseline in glycated hemoglobin | 120 days |
| Systolic blood pressure (SBP) | Changes from baseline in SBP in ambulatory blood pressure monitoring | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events recorded during the study | 150 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Atenas placebo | Drug | Drug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day |
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| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |