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The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Lercanidipine 10 mg | Experimental |
| |
| Lercanidipine 20 mg | Experimental |
| |
| Enalapril 10 mg | Experimental |
| |
| Enalapril 20 mg | Experimental |
| |
| Lercanidipine 10 mg/Enalapril 10 mg | Experimental |
| |
| Lercanidipine 10mg/Enalapril 20 mg | Experimental |
| |
| Lercanidipine 20mg/Enalapril 10 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | once daily for 10 weeks |
| |
| Lercanidipine |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting diastolic blood pressure (SDBP) | after 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting systolic blood pressure (SSBP) | after 10 weeks | |
| Safety parameters: adverse events, heart rate, laboratory tests physical examination | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Mancia, Prof | Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Pitié-Salpétrière | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26630216 | Derived | Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2020 | |
| Reset | Nov 23, 2020 |
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| Experimental |
|
| Lercanidipine 20mg/Enalapril20mg | Experimental |
|
| Drug |
10 mg once daily for 10 weeks |
|
| Lercanidipine | Drug | 20 mg once daily for 10 weeks |
|
| Enalapril | Drug | 10 mg once daily for 10 weeks |
|
| Enalapril | Drug | 20 mg once daily for 10 weeks |
|
| Lercanidipine + Enalapril | Drug | 10/10 mg once daily for 10 weeks |
|
| Lercanidipine + Enalapril | Drug | 10/20 mg once daily for 10 weeks |
|
| Lercanidipine + Enalapril | Drug | 20/10 mg once daily for 10 weeks |
|
| Lercanidipine + Enalapril | Drug | 20/20 mg once daily for 10 weeks |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2020 | Nov 23, 2020 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C060343 | lercanidipine |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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