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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
The purpose of this clinical research is to learn if moderate 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 |
| |
| A3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan/HCTZ | Drug | Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in SeSBP at Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy. |
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Inclusion Criteria:
Willing to provide written informed consent
Subjects must have uncontrolled hypertension defined as:
Subjects must be willing to discontinue their antihypertensive medication, if applicable.
Men and women, ages 18 and older will be included.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
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, 12 weeks. |
|
|
| HCTZ monotherapy | Drug | Tablets, Oral, 12.5 mg, Once daily, 12 weeks. |
|
| Columbiana |
| Alabama |
| United States |
| Local Institution | Mesa | Arizona | United States |
| Local Institution | Phoenix | Arizona | United States |
| Local Institution | Carmichael | California | United States |
| Local Institution | Fair Oaks | California | United States |
| Local Institution | Fresno | California | United States |
| Local Institution | Long 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 Jose | California | United States |
| Local Institution | Torrance | California | United States |
| Local Institution | Tustin | California | United States |
| Local Institution | Highlands Ranch | Colorado | United States |
| Local Institution | Bridgeport | Connecticut | United States |
| Local Institution | Waterbury | Connecticut | United States |
| Local Institution | Newark | Delaware | United States |
| Local Institution | Chipley | Florida | United States |
| Local Institution | Clearwater | 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 | Miami | Florida | United States |
| Local Institution | Niceville | Florida | United States |
| Local Institution | Ocoee | Florida | United States |
| Local Institution | Pembroke Pines | Florida | United States |
| Local Institution | Saint Cloud | Florida | United States |
| Local Institution | Atlanta | Georgia | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Peoria | Illinois | United States |
| Local Institution | Chalmette | Louisiana | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | Oxon Hill | Maryland | United States |
| Local Institution | Springfield | Massachusetts | United States |
| Local Institution | Livonia | Michigan | United States |
| Local Institution | Saginaw | Michigan | United States |
| Local Institution | Olive Branch | Mississippi | United States |
| Local Institution | Missoula | Montana | United States |
| Local Institution | Dover | New Hampshire | United States |
| Local Institution | South Bound Brook | New Jersey | United States |
| Local Institution | Buffalo | New York | United States |
| Local Institution | Mount Vernon | New York | United States |
| Local Institution | New York | 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 | Mint Hill | 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 | Genoa | Ohio | United States |
| Local Institution | Kettering | Ohio | United States |
| Local Institution | Lyndhurst | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Eugene | Oregon | United States |
| Local Institution | Medford | 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 | Charleston | South Carolina | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Orangeburg | 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 | Hendersonville | Tennessee | United States |
| Local Institution | Nashville | Tennessee | United States |
| Local Institution | Selmer | Tennessee | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Colleyville | Texas | United States |
| Local Institution | Midland | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Salt Lake City | Utah | United States |
| Local Institution | Charlottesville | Virginia | 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 | Red Deer | Alberta | Canada |
| Local Institution | Coquitlam | British Columbia | Canada |
| Local Institution | North Vancouver | 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 | Markham | 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 | Montague | Prince Edward Island | Canada |
| Local Institution | Drummondville | Quebec | Canada |
| Local Institution | Greenfield Park | Quebec | Canada |
| Local Institution | Saint-Lambert | Quebec | Canada |
| Local Institution | Saskatoon | Saskatchewan | Canada |
| Local Institution | Angers | France |
| Local Institution | Bouchemaine | France |
| Local Institution | Briollay | France |
| Local Institution | Tiercé | France |
| Local Institution | Spaichingen | Baden-Wurttembe | Germany |
| Local Institution | Spaichingen | Braden-Wurttembe | Germany |
| Local Institution | Berlin | Germany |
| Local Institution | Essen | Germany |
| Local Institution | Feldafing | Germany |
| Local Institution | Grömitz | Germany |
| Local Institution | Künzing | Germany |
| Local Institution | Nörten-Hardenberg | Germany |
| Local Institution | Nuremberg | Germany |
| Local Institution | Ornbau | Germany |
| Local Institution | Unterschneidheim | Germany |
| Local Institution | Villingen-Schwenningen | Germany |
| 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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