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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril + Irbesartan | Drug | Tablets + Capsules, Oral, 10mg Ramipril + 300mg Irbesartan target dose, Once daily, 20 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in AER from baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seated systolic and diastolic blood pressures at Week 20; Comparison of change from baseline in seated systolic and diastolic blood pressures at Week 20 between treatment groups |
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Inclusion Criteria:
Subjects must be willing and able to provide written informed consent.
Males and Females 55 years of age and over
Subjects must have a history of high blood pressure and elevated cardiovascular risk defined as one of the following:
All subjects must also have albuminuria (protein in the urine) that is confirmed by a urine test at the first study visit.
All subjects must currently be treated with a class of drugs called ACE inhibitors (e.g., benazepril, captopril, enalapril, lisinopril, moexipril, ramipril, quinapril, perindopril) for at least 2 months prior to the study.
Women of childbearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy throughout the study and four weeks after the study ends.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Tustin | California | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17667984 | Derived | Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1. |
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| Ramipril + Placebo | Drug | Tablets + Capsules, Oral, 10mg Ramipril + 300mg Placebo target dose, Once daily, 20 weeks. |
|
| Miami |
| Florida |
| United States |
| Local Institution | West Palm Beach | Florida | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Flushing | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Providence | Rhode Island | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Milwaukee | Wisconsin | United States |
| Local Institution | Burwood | New South Wales | Australia |
| Local Institution | Camperdown | New South Wales | Australia |
| Local Institution | Gosford | New South Wales | Australia |
| Local Institution | St Leonards | New South Wales | Australia |
| Local Institution | Woolloongabba | Queensland | Australia |
| Local Institution | Box Hill | Victoria | Australia |
| Local Institution | Fitzroy | Victoria | Australia |
| Local Institution | Parkville | Victoria | Australia |
| Local Institution | Fremantle | Western Australia | Australia |
| Local Institution | Edmonton | Alberta | Canada |
| Local Institution | Vancouver | British Columbia | Canada |
| Local Institution | Winnipeg | Manitoba | Canada |
| Local Institution | Halifax | Nova Scotia | Canada |
| Local Institution | Scarborough Village | Ontario | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Laval | Quebec | Canada |
| Local Institution | Longueuil | Quebec | Canada |
| Local Institution | Boulogne-sur-Mer | France |
| Local Institution | Colmar | France |
| Local Institution | Grenoble | France |
| Local Institution | Pessac | France |
| Local Institution | Strasbourg | France |
| Local Institution | Aschaffenburg | Germany |
| Local Institution | Bad Mergentheim | Germany |
| Local Institution | Göttingen | Germany |
| Local Institution | Halle | Germany |
| Local Institution | Künzing | Germany |
| Local Institution | München | Germany |
| Local Institution | Ornbau | Germany |
| Local Institution | Vellmar | Germany |
| Local Institution | Villingen-Schwenningen | Germany |
| Local Institution | Ashkelon | Israel |
| Local Institution | Beersheba | Israel |
| Local Institution | Hadera | Israel |
| Local Institution | Holon | Israel |
| Local Institution | Jerusalem | Israel |
| Local Institution | Kfar Saba | Israel |
| Local Institution | Kiryat Biyalik | Israel |
| Local Institution | Nazareth | Israel |
| Local Institution | Ramat Gan | Israel |
| Local Institution | Rehovot | Israel |
| Local Institution | Tel Aviv | Israel |
| Local Institution | Ẕerifin | Israel |
| Local Institution | Chieri | Italy |
| Local Institution | Genova | Italy |
| Local Institution | Lecco | Italy |
| Local Institution | Naples | Italy |
| Local Institution | Rimini | Italy |
| Local Institution | Rome | Italy |
| Local Institution | San Benedetto del Tronto | Italy |
| Local Institution | Daugavpils | Latvia |
| Local Institution | Riga | Latvia |
| Local Institution | Kaunas | Lithuania |
| Local Institution | Klaipėda | Lithuania |
| Local Institution | Panevezys | Lithuania |
| Local Institution | Šiauliai | Lithuania |
| Local Institution | Vilnius | Lithuania |
| Local Institution | Aguascalientes | Aguascalientes | Mexico |
| Local Institution | Guadalajara | Jalisco | Mexico |
| Local Institution | Mexico City | Mexico City | Mexico |
| Local Institution | Morelia | Michioacan | Mexico |
| Local Institution | Monterrey | Nuevo León | Mexico |
| Local Institution | México | San Lis Potosi | Mexico |
| Local Institution | Amsterdam | Netherlands |
| Local Institution | Blaricum | Netherlands |
| Local Institution | Eindhoven | Netherlands |
| Local Institution | Groningen | Netherlands |
| Local Institution | Stadskanaal | Netherlands |
| Local Institution | Zeist | Netherlands |
| Local Institution | Zwolle | Netherlands |
| Local Institution | Moscow | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Barcelona | Spain |
| Local Institution | Jerez de la Frontera | Spain |
| Local Institution | Las Palmas de G. C. | Spain |
| Local Institution | Madrid | Spain |
| Local Institution | Marbella | Spain |
| Local Institution | Middlesbrough | Cleveland | United Kingdom |
| Local Institution | Belfast | County Durham | United Kingdom |
| Local Institution | Birmingham | West Midlands | United Kingdom |
| Local Institution | Derby | West Midlands | United Kingdom |
| ID | Term |
|---|---|
| D000419 | Albuminuria |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |
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