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Sponsor decision
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The purpose of this study is to evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LENINGRADO | Experimental | The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day. |
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| Indapamide | Active Comparator | The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day. |
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| Levamlodipine | Active Comparator | The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LENINGRADO association | Drug | 1 coated sustained-release tablet, oral, once a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events recorded during the study | 70 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542574 | levamlodipine |
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| Indapamide SR 1.5 MG | Drug | 1 coated sustained-release tablet, oral, once a day. |
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| Levamlodipine 2.5/ 5 mg | Drug | 1 tablet, oral, once a day. |
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| Leningrado association Placebo | Other | 1 coated sustained-release tablet, oral, once a day. |
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| Indapamide SR Placebo | Other | 1 coated sustained-release tablet, oral, once a day. |
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| Levamlodipine placebo | Other | 1 tablet, oral, once a day. |
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