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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan/HCTZ | Drug | Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Birmingham | Alabama | United States | |||
| Local Institution |
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| Irbesartan monotherapy | Drug | Tablets, Oral, 150 mg, Once daily, 7 weeks. |
|
|
| Columbiana |
| Alabama |
| United States |
| Local Institution | Huntsville | Alabama | United States |
| Local Institution | Mesa | Arizona | United States |
| Local Institution | Phoenix | Arizona | United States |
| Local Institution | Scottsdale | Arizona | United States |
| Local Institution | Sherwood | Arkansas | United States |
| Local Institution | Carlsbad | California | United States |
| Local Institution | Carmichael | California | United States |
| Local Institution | Corona | California | United States |
| Local Institution | Encinitas | California | United States |
| Local Institution | Fresno | California | United States |
| Local Institution | Laguna Hills | California | United States |
| Local Institution | Long Beach | California | United States |
| Local Institution | Mission Hills | California | United States |
| Local Institution | Raleigh | California | United States |
| Local Institution | Redondo Beach | California | United States |
| Local Institution | Rolling Hills Estate | California | United States |
| Local Institution | Roseville | California | United States |
| Local Institution | Sacramento | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | San Jose | California | United States |
| Local Institution | Santa Ana | California | United States |
| Local Institution | Torrance | California | United States |
| Local Institution | Tustin | California | United States |
| Local Institution | Boulder | Colorado | United States |
| Local Institution | Denver | Colorado | United States |
| Local Institution | Highlands Ranch | Colorado | United States |
| Local Institution | Wheat Ridge | Colorado | United States |
| Local Institution | Bridgeport | Connecticut | United States |
| Local Institution | Waterbury | Connecticut | United States |
| Local Institution | Newark | Delaware | United States |
| Local Institution | Charlotte Harbour | Florida | United States |
| Local Institution | Chipley | Florida | United States |
| Local Institution | Clearwater | Florida | United States |
| Local Institution | Cocoa Beach | Florida | United States |
| Local Institution | Crestview | Florida | United States |
| Local Institution | DeLand | Florida | United States |
| Local Institution | Hollywood | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Jupiter | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Niceville | Florida | United States |
| Local Institution | North Miami Beach | Florida | United States |
| Local Institution | Ocala | Florida | United States |
| Local Institution | Ocoee | Florida | United States |
| Local Institution | Pembroke Pines | Florida | United States |
| Local Institution | Port Orange | Florida | United States |
| Local Institution | Saint Cloud | Florida | United States |
| Local Institution | Sarasota | Florida | United States |
| Local Institution | Tamarac | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Vero Beach | Florida | United States |
| Local Institution | Zephyrhills | Florida | United States |
| Local Institution | Atlanta | Georgia | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Peoria | Illinois | United States |
| Local Institution | Vernon Hills | Illinois | United States |
| Local Institution | Des Moines | Iowa | United States |
| Local Institution | Kansas City | Kansas | United States |
| Local Institution | Wichita | Kansas | United States |
| Local Institution | Erlanger | Kentucky | United States |
| Local Institution | Richmond | Kentucky | United States |
| Local Institution | Chalmette | Louisiana | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | Elkton | Maryland | United States |
| Local Institution | Oxon Hill | Maryland | United States |
| Local Institution | Ayer | Massachusetts | United States |
| Local Institution | Springfield | Massachusetts | United States |
| Local Institution | Sudbury | Massachusetts | United States |
| Local Institution | Livonia | Michigan | United States |
| Local Institution | Saginaw | Michigan | United States |
| Local Institution | Cleveland | Mississippi | United States |
| Local Institution | Olive Branch | Mississippi | United States |
| Local Institution | Picayune | Mississippi | United States |
| Local Institution | Manchester | Missouri | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Butte | Montana | United States |
| Local Institution | Missoula | Montana | United States |
| Local Institution | Omaha | Nebraska | United States |
| Local Institution | Las Vegas | Nevada | United States |
| Local Institution | Dover | New Hampshire | United States |
| Local Institution | Hillsborough | New Jersey | United States |
| Local Institution | South Bound Brook | New Jersey | United States |
| Local Institution | Albuquerque | New Mexico | United States |
| Local Institution | Buffalo | New York | United States |
| Local Institution | East Syracuse | New York | United States |
| Local Institution | Fulton | New York | United States |
| Local Institution | Lake Success | New York | United States |
| Local Institution | Mount Vernon | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Olean | New York | United States |
| Local Institution | The Bronx | New York | United States |
| Local Institution | Charlotte | North Carolina | United States |
| Local Institution | Gastonia | North Carolina | United States |
| Local Institution | Greensboro | North Carolina | United States |
| Local Institution | High Point | North Carolina | United States |
| Local Institution | Mint Hill | North Carolina | United States |
| Local Institution | Nashville | North Carolina | United States |
| Local Institution | Wilmington | North Carolina | United States |
| Local Institution | Winston-Salem | North Carolina | United States |
| Local Institution | Canton | Ohio | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Columbus | Ohio | United States |
| Local Institution | Genoa | Ohio | United States |
| Local Institution | Kettering | Ohio | United States |
| Local Institution | Lyndhurst | Ohio | United States |
| Local Institution | Perrysburg | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Tulsa | Oklahoma | United States |
| Local Institution | Eugene | Oregon | United States |
| Local Institution | Medford | Oregon | United States |
| Local Institution | Orangeburg | Oregon | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Bensalem | Pennsylvania | United States |
| Local Institution | Camp Hill | Pennsylvania | United States |
| Local Institution | Collegeville | Pennsylvania | United States |
| Local Institution | Levittown | Pennsylvania | United States |
| Local Institution | Penndel | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | West Grove | Pennsylvania | United States |
| Local Institution | Cranston | Rhode Island | United States |
| Local Institution | Charleston | South Carolina | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Landrum | South Carolina | United States |
| Local Institution | Prosperity | South Carolina | United States |
| Local Institution | Saluda | South Carolina | United States |
| Local Institution | Simpsonville | South Carolina | United States |
| Local Institution | Summerville | South Carolina | United States |
| Local Institution | Bartlett | Tennessee | United States |
| Local Institution | Bristol | Tennessee | United States |
| Local Institution | Cordova | Tennessee | United States |
| Local Institution | Hendersonville | Tennessee | United States |
| Local Institution | Johnson City | Tennessee | United States |
| Local Institution | Morristown | Tennessee | United States |
| Local Institution | Nashville | Tennessee | United States |
| Local Institution | New Tazewell | Tennessee | United States |
| Local Institution | Selmer | Tennessee | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Colleyville | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Lake Jackson | Texas | United States |
| Local Institution | Midland | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | The Colony | Texas | United States |
| Local Institution | Salt Lake City | Utah | United States |
| Local Institution | Burke | Virginia | United States |
| Local Institution | Charlottesville | Virginia | United States |
| Local Institution | Hampton | Virginia | United States |
| Local Institution | Norfolk | Virginia | United States |
| Local Institution | Lacey | Washington | United States |
| Local Institution | Olympia | Washington | United States |
| Local Institution | Spokane | Washington | United States |
| Local Institution | Madison | Wisconsin | United States |
| Local Institution | Milwaukee | Wisconsin | United States |
| Local Institution | Huy | Luik | Belgium |
| Local Institution | Antwerp | Belgium |
| Local Institution | Brussels | Belgium |
| Local Institution | Edegem | Belgium |
| Local Institution | Genk | Belgium |
| Local Institution | Hasselt | Belgium |
| Local Institution | La Louvière | Belgium |
| Local Institution | Liège | Belgium |
| Local Institution | Roeselare | Belgium |
| Local Institution | Wilrijk | Belgium |
| Local Institution | Edmonton | Alberta | Canada |
| Local Institution | Red Deer | Alberta | Canada |
| Local Institution | Coquitlam | British Columbia | Canada |
| Local Institution | North Vancouver | British Columbia | Canada |
| Local Institution | Quesnel | British Columbia | Canada |
| Local Institution | Sidney | British Columbia | Canada |
| Local Institution | Winnipeg | Manitoba | Canada |
| Local Institution | St. John's | Newfoundland and Labrador | Canada |
| Local Institution | Halifax | Nova Scotia | Canada |
| Local Institution | Aylmer | Ontario | Canada |
| Local Institution | Burlington | Ontario | Canada |
| Local Institution | Hamilton | Ontario | Canada |
| Local Institution | London | Ontario | Canada |
| Local Institution | Markham | Ontario | Canada |
| Local Institution | Niagra Falls | Ontario | Canada |
| Local Institution | Oakville | Ontario | Canada |
| Local Institution | Oshawa | Ontario | Canada |
| Local Institution | Richmond Hill | Ontario | Canada |
| Local Institution | Sarnia | Ontario | Canada |
| Local Institution | Thornhill | Ontario | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Windsor | Ontario | Canada |
| Local Institution | Montague | Prince Edward Island | Canada |
| Local Institution | Bonaventure | Quebec | Canada |
| Local Institution | Chandler | Quebec | Canada |
| Local Institution | Chicoutimi | Quebec | Canada |
| Local Institution | Drummondville | Quebec | Canada |
| Local Institution | Greenfield Park | Quebec | Canada |
| Local Institution | Montreal | Quebec | Canada |
| Local Institution | Saint-Lambert | Quebec | Canada |
| Local Institution | Ste-Foy | Quebec | Canada |
| Local Institution | Saskatoon | Saskatchewan | Canada |
| Local Institution | Ambrières-les-Vallées | France |
| Local Institution | Angers | France |
| Local Institution | Bagneux | France |
| Local Institution | Bouère | France |
| Local Institution | Château-Gontier | France |
| Local Institution | Cherbourg | France |
| Local Institution | Équeurdreville-Hainneville | France |
| Local Institution | Évron | France |
| Local Institution | La Glacerie | France |
| Local Institution | La Rochelle | France |
| Local Institution | Laval | France |
| Local Institution | Le Lion-dAngers | France |
| Local Institution | Longue | France |
| Local Institution | Longué-Jumelles | France |
| Local Institution | Louverné | France |
| Local Institution | Mayenne | France |
| Local Institution | Nieul-sur-Mer | France |
| Local Institution | Noyant | France |
| Local Institution | Sainte-Suzanne | France |
| Local Institution | Saumur | France |
| Local Institution | Villebernier | France |
| Local Institution | Spaichingen | Baden-Wurttembe | Germany |
| Local Institution | Loxstedt | Niedersach | Germany |
| Local Institution | Beckum | Germany |
| Local Institution | Berlin | Germany |
| Local Institution | Blankenhain | Germany |
| Local Institution | Essen | Germany |
| Local Institution | Flörsheim | Germany |
| Local Institution | Frankfurt | Germany |
| Local Institution | Fürth | Germany |
| Local Institution | Georgsmarienhütte | Germany |
| Local Institution | Germersheim | Germany |
| Local Institution | Hamburg | Germany |
| Local Institution | Hanover | Germany |
| Local Institution | Krombach | Germany |
| Local Institution | Künzing | Germany |
| Local Institution | Lambrecht | Germany |
| Local Institution | Mainburg | Germany |
| Local Institution | Mannheim | Germany |
| Local Institution | Messkirch | Germany |
| Local Institution | Monheim | Germany |
| Local Institution | Nuremberg | Germany |
| Local Institution | Parsberg | Germany |
| Local Institution | Pforzheim | Germany |
| Local Institution | Stuttgart | Germany |
| Local Institution | Villingen-Schwenningen | Germany |
| Local Institution | Waldbrunn | Germany |
| Local Institution | Welver | Germany |
| Local Institution | Beersheba | Israel |
| Local Institution | Haifa | Israel |
| Local Institution | Holon | Israel |
| Local Institution | Jerusalem | Israel |
| Local Institution | Kfar Saba | Israel |
| Local Institution | Matan | Israel |
| Local Institution | Tel Litwinsky | Israel |
| Local Institution | Ẕerifin | Israel |
| Local Institution | Beek en Donk | Netherlands |
| Local Institution | Eindhoven | Netherlands |
| Local Institution | Hardenberg | Netherlands |
| Local Institution | Heerlen | Netherlands |
| Local Institution | Lichtenvoorde | Netherlands |
| Local Institution | Rijswyk Zh | Netherlands |
| Local Institution | The Hague | Netherlands |
| Local Institution | Tilburg | Netherlands |
| Local Institution | Venlo | Netherlands |
| Local Institution | Waalwijk | Netherlands |
| Local Institution | Woerden | Netherlands |
| Local Institution | Zeist | Netherlands |
| Local Institution | Moscow | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Saratov | Russia |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| 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 |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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