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.

Condition	Treatment or Intervention	Phase
Hypertension	Drug: Irbesartan/HCTZ	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Men and women ages 18 and older;
• Willing to provide written informed consent;
• Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
• Must be willing to discontinue antihypertensive medication, if applicable;
• 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:

• Women who are pregnant or breastfeeding;
• Known or suspected secondary hypertension;
• Hypertension emergencies or stroke within the past 12 months;
• Heart attack, angina or bypass surgery within the past 6 months;
• Significant kidney disease;
• Significant liver disease;
• Systemic lupus erythematosus;
• Gastrointestinal disease or surgery that may interfere with drug absorption;
• Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
• Currently pregnant or lactating;
• Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
• Drug or alcohol abuse within the last five years;
• Known allergy to irbesartan or diuretics.

BMS Call Center      1-866-892-1BMS  Ext. 141 
BMS Call Center Outside the US and Canada      1-215-347- 4079  Ext. 141 

Alabama
      Local Institution, Huntsville,  Alabama,  United States; Recruiting
      Local Institution, Columbiana,  Alabama,  United States; Recruiting
      Local Institution, Birmingham,  Alabama,  United States; Recruiting
Arizona
      Local Institution, Mesa,  Arizona,  United States; Recruiting
      Local Institution, Phoenix,  Arizona,  United States; Recruiting
      Local Institution, Scottsdale,  Arizona,  United States; Not yet recruiting
Arkansas
      Local Institution, Sherwood,  Arkansas,  United States; Not yet recruiting
California
      Local Institution, Long Beach,  California,  United States; Recruiting
      Local Institution, San Diego,  California,  United States; Recruiting
      Local Institution, Mission Hills,  California,  United States; Recruiting
      Local Institution, Sacramento,  California,  United States; Recruiting
      Local Institution, San Jose,  California,  United States; Recruiting
      Local Institution, Tustin,  California,  United States; Recruiting
      Local Institution, Fresno,  California,  United States; Recruiting
      Local Institution, Torrance,  California,  United States; Recruiting
      Local Institution, Raleigh,  California,  United States; No longer recruiting
      Local Institution, Carlsbad,  California,  United States; Recruiting
      Local Institution, Rolling Hills Estate,  California,  United States; Recruiting
      Local Institution, Roseville,  California,  United States; Recruiting
      Local Institution, Carmichael,  California,  United States; Recruiting
      Local Institution, Laguna Hills,  California,  United States; Not yet recruiting
      Local Institution, Santa Ana,  California,  United States; Not yet recruiting
      Local Institution, Corona,  California,  United States; Not yet recruiting
      Local Institution, Encinitas,  California,  United States; Not yet recruiting
      Local Institution, Redondo Beach,  California,  United States; Not yet recruiting
Colorado
      Local Institution, Boulder,  Colorado,  United States; No longer recruiting
      Local Institution, Highlands Ranch,  Colorado,  United States; Recruiting
      Local Institution, Wheat Ridge,  Colorado,  United States; Not yet recruiting
      Local Institution, Denver,  Colorado,  United States; Not yet recruiting
Connecticut
      Local Institution, Bridgeport,  Connecticut,  United States; Recruiting
      Local Institution, Waterbury,  Connecticut,  United States; Recruiting
Delaware
      Local Institution, Newark,  Delaware,  United States; Recruiting
Florida
      Local Institution, Jacksonville,  Florida,  United States; Recruiting
      Local Institution, North Miami Beach,  Florida,  United States; Not yet recruiting
      Local Institution, Ocoee,  Florida,  United States; Recruiting
      Local Institution, Clearwater,  Florida,  United States; Recruiting
      Local Institution, Pembroke Pines,  Florida,  United States; Recruiting
      Local Institution, Charlotte Harbour,  Florida,  United States; Recruiting
      Local Institution, Ocala,  Florida,  United States; No longer recruiting
      Local Institution, Deland,  Florida,  United States; Recruiting
      Local Institution, Hollywood,  Florida,  United States; Recruiting
      Local Institution, Port Orange,  Florida,  United States; Not yet recruiting
      Local Institution, St. Cloud,  Florida,  United States; Recruiting
      Local Institution, Miami,  Florida,  United States; Recruiting
      Local Institution, Niceville,  Florida,  United States; Recruiting
      Local Institution, Crestview,  Florida,  United States; Recruiting
      Local Institution, Chipley,  Florida,  United States; Recruiting
      Local Institution, Cocoa Beach,  Florida,  United States; Not yet recruiting
      Local Institution, Jupiter,  Florida,  United States; Not yet recruiting
      Local Institution, Sarasota,  Florida,  United States; Not yet recruiting
      Local Institution, Tamarac,  Florida,  United States; Not yet recruiting
      Local Institution, Zephyrhills,  Florida,  United States; Not yet recruiting
      Local Institution, Tampa,  Florida,  United States; Not yet recruiting
      Local Institution, Vero Beach,  Florida,  United States; Not yet recruiting
Georgia
      Local Institution, Atlanta,  Georgia,  United States; Recruiting
Illinois
      Local Institution, Vernon Hills,  Illinois,  United States; Recruiting
      Local Institution, Peoria,  Illinois,  United States; Recruiting
      Local Institution, Chicago,  Illinois,  United States; Recruiting
Iowa
      Local Institution, Des Moines,  Iowa,  United States; Recruiting
Kansas
      Local Institution, Wichita,  Kansas,  United States; Recruiting
      Local Institution, Kansas City,  Kansas,  United States; Recruiting
Kentucky
      Local Institution, Erlanger,  Kentucky,  United States; Not yet recruiting
      Local Institution, Richmond,  Kentucky,  United States; Not yet recruiting
Louisiana
      Local Institution, Chalmette,  Louisiana,  United States; Recruiting
      Local Institution, New Orleans,  Louisiana,  United States; Recruiting
Maryland
      Local Institution, Baltimore,  Maryland,  United States; Recruiting
      Local Institution, Oxon Hill,  Maryland,  United States; Recruiting
      Local Institution, Elkton,  Maryland,  United States; Not yet recruiting
Massachusetts
      Local Institution, Springfield,  Massachusetts,  United States; Recruiting
      Local Institution, Ayer,  Massachusetts,  United States; Recruiting
      Local Institution, Sudbury,  Massachusetts,  United States; Recruiting
Michigan
      Local Institution, Livonia,  Michigan,  United States; Recruiting
      Local Institution, Saginaw,  Michigan,  United States; Recruiting
Mississippi
      Local Institution, Cleveland,  Mississippi,  United States; Recruiting
      Local Institution, Picayune,  Mississippi,  United States; Recruiting
      Local Institution, Olive Branch,  Mississippi,  United States; Recruiting
Missouri
      Local Institution, St. Louis,  Missouri,  United States; Recruiting
      Local Institution, Manchester,  Missouri,  United States; Not yet recruiting
Montana
      Local Institution, Missoula,  Montana,  United States; Recruiting
      Local Institution, Butte,  Montana,  United States; Not yet recruiting
Nebraska
      Local Institution, Omaha,  Nebraska,  United States; Not yet recruiting
Nevada
      Local Institution, Las Vegas,  Nevada,  United States; Recruiting
New Hampshire
      Local Institution, Dover,  New Hampshire,  United States; Recruiting
New Jersey
      Local Institution, South Bound Brook,  New Jersey,  United States; Recruiting
      Local Institution, Hillsborough,  New Jersey,  United States; Recruiting
New Mexico
      Local Institution, Albuquerque,  New Mexico,  United States; Not yet recruiting
New York
      Local Institution, Mt. Vernon,  New York,  United States; Recruiting
      Local Institution, Bronx,  New York,  United States; Recruiting
      Local Institution, Lake Success,  New York,  United States; No longer recruiting
      Local Institution, New York,  New York,  United States; No longer recruiting
      Local Institution, Buffalo,  New York,  United States; Recruiting
      Local Institution, Fulton,  New York,  United States; Not yet recruiting
      Local Institution, Olean,  New York,  United States; No longer recruiting
      Local Institution, East Syracuse,  New York,  United States; Not yet recruiting
North Carolina
      Local Institution, Charlotte,  North Carolina,  United States; Recruiting
      Local Institution, Winston Salem,  North Carolina,  United States; Recruiting
      Local Institution, Mint Hill,  North Carolina,  United States; Recruiting
      Local Institution, Charlotte,  North Carolina,  United States; Recruiting
      Local Institution, Gastonia,  North Carolina,  United States; Recruiting
      Local Institution, Greensboro,  North Carolina,  United States; Recruiting
      Local Institution, High Point,  North Carolina,  United States; Recruiting
      Local Institution, Nashville,  North Carolina,  United States; Recruiting
      Local Institution, Wilmington,  North Carolina,  United States; Recruiting
Ohio
      Local Institution, Columbus,  Ohio,  United States; No longer recruiting
      Local Institution, Lyndhurst,  Ohio,  United States; Recruiting
      Local Institution, Cincinnati,  Ohio,  United States; Recruiting
      Local Institution, Genoa,  Ohio,  United States; Recruiting
      Local Institution, Kettering,  Ohio,  United States; Recruiting
      Local Institution, Canton,  Ohio,  United States; Recruiting
      Local Institution, Perrysburg,  Ohio,  United States; Not yet recruiting
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States; Recruiting
      Local Institution, Tulsa,  Oklahoma,  United States; Not yet recruiting
Oregon
      Local Institution, Portland,  Oregon,  United States; Recruiting
      Local Institution, Medford,  Oregon,  United States; Recruiting
      Local Institution, Eugene,  Oregon,  United States; Recruiting
      Local Institution, Orangeburg,  Oregon,  United States; Recruiting
Pennsylvania
      Local Institution, Camp Hill,  Pennsylvania,  United States; Recruiting
      Local Institution, Philadelphia,  Pennsylvania,  United States; Recruiting
      Local Institution, Collegeville,  Pennsylvania,  United States; Recruiting
      Local Institution, Penndel,  Pennsylvania,  United States; Recruiting
      Local Institution, Bensalem,  Pennsylvania,  United States; Recruiting
      Local Institution, West Grove,  Pennsylvania,  United States; Recruiting
      Local Institution, Levittown,  Pennsylvania,  United States; Recruiting
Rhode Island
      Local Institution, Cranston,  Rhode Island,  United States; Recruiting
South Carolina
      Local Institution, Summerville,  South Carolina,  United States; Recruiting
      Local Institution, Columbia,  South Carolina,  United States; Recruiting
      Local Institution, Charleston,  South Carolina,  United States; Recruiting
      Local Institution, Simpsonville,  South Carolina,  United States; Recruiting
      Local Institution, Saluda,  South Carolina,  United States; No longer recruiting
      Local Institution, Saluda,  South Carolina,  United States; Recruiting
      Local Institution, Landrum,  South Carolina,  United States; Recruiting
      Local Institution, Prosperity,  South Carolina,  United States; Recruiting
Tennessee
      Local Institution, Bartlett,  Tennessee,  United States; Recruiting
      Local Institution, Selmer,  Tennessee,  United States; Recruiting
      Local Institution, Nashville,  Tennessee,  United States; Recruiting
      Local Institution, Cordova,  Tennessee,  United States; No longer recruiting
      Local Institution, Hendersonville,  Tennessee,  United States; Recruiting
      Local Institution, Bristol,  Tennessee,  United States; Not yet recruiting
      Local Institution, Morristown,  Tennessee,  United States; Not yet recruiting
      Local Institution, Johnson City,  Tennessee,  United States; Not yet recruiting
      Local Institution, New Tazewell,  Tennessee,  United States; Not yet recruiting
Texas
      Local Institution, Austin,  Texas,  United States; Recruiting
      Local Institution, San Antonio,  Texas,  United States; Recruiting
      Local Institution, Midland,  Texas,  United States; Recruiting
      Local Institution, Lake Jackson,  Texas,  United States; No longer recruiting
      Local Institution, Colleyville,  Texas,  United States; Recruiting
      Local Institution, Dallas,  Texas,  United States; Not yet recruiting
      Local Institution, The Colony,  Texas,  United States; Not yet recruiting
Utah
      Local Institution, Salt Lake City,  Utah,  United States; Not yet recruiting
Virginia
      Local Institution, Charlottesville,  Virginia,  United States; Recruiting
      Local Institution, Hampton,  Virginia,  United States; Recruiting
      Local Institution, Burke,  Virginia,  United States; Recruiting
      Local Institution, Norfolk,  Virginia,  United States; No longer recruiting
Washington
      Local Institution, Spokane,  Washington,  United States; Recruiting
      Local Institution, Olympia,  Washington,  United States; Recruiting
      Local Institution, Lacey,  Washington,  United States; Recruiting
Wisconsin
      Local Institution, Madison,  Wisconsin,  United States; Recruiting
      Local Institution, Milwaukee,  Wisconsin,  United States; Recruiting
Belgium
      Local Institution, Antwerpen,  Belgium; Recruiting
      Local Institution, Brussels,  Belgium; Recruiting
      Local Institution, BRUXELLES,  Belgium; Recruiting
      Local Institution, Edegem,  Belgium; Recruiting
      Local Institution, Genk,  Belgium; Not yet recruiting
      Local Institution, Hasselt,  Belgium; Not yet recruiting
      Local Institution, La Louviere,  Belgium; Recruiting
      Local Institution, LIEGE,  Belgium; Recruiting
      Local Institution, Wilrijk,  Belgium; Recruiting
      Local Institution, Roeselare,  Belgium; Recruiting
Belgium, Luik
      Local Institution, Huy,  Luik,  Belgium; Recruiting
Canada, Alberta
      Local Institution, Red Deer,  Alberta,  Canada; Recruiting
      Local Institution, Edmonton,  Alberta,  Canada; Recruiting
Canada, British Columbia
      Local Institution, North Vancouver,  British Columbia,  Canada; Recruiting
      Local Institution, Sidney,  British Columbia,  Canada; Recruiting
      Local Institution, Quesnel,  British Columbia,  Canada; Not yet recruiting
      Local Institution, Coquitlam,  British Columbia,  Canada; Recruiting
Canada, Manitoba
      Local Institution, Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Local Institution, St. Johns,  Newfoundland and Labrador,  Canada; Recruiting
Canada, Nova Scotia
      Local Institution, Halifax,  Nova Scotia,  Canada; Recruiting
Canada, Ontario
      Local Institution, Toronto,  Ontario,  Canada; Recruiting
      Local Institution, Burlington,  Ontario,  Canada; Recruiting
      Local Institution, Hamilton,  Ontario,  Canada; Recruiting
      Local Institution, Oshawa,  Ontario,  Canada; Recruiting
      Local Institution, Markham,  Ontario,  Canada; Recruiting
      Local Institution, Thornhill,  Ontario,  Canada; Recruiting
      Local Institution, Sarnia,  Ontario,  Canada; Recruiting
      Local Institution, Aylmer,  Ontario,  Canada; Recruiting
      Local Institution, Oakville,  Ontario,  Canada; Recruiting
      Local Institution, Richmond Hill,  Ontario,  Canada; Recruiting
      Local Institution, Niagra Falls,  Ontario,  Canada; Recruiting
      Local Institution, Windsor,  Ontario,  Canada; Recruiting
      Local Institution, London,  Ontario,  Canada; Recruiting
Canada, Prince Edward Island
      Local Institution, Montague,  Prince Edward Island,  Canada; Recruiting
Canada, Quebec
      Local Institution, Bonaventure,  Quebec,  Canada; Not yet recruiting
      Local Institution, Greenfield Park,  Quebec,  Canada; Recruiting
      Local Institution, Chandler,  Quebec,  Canada; Not yet recruiting
      Local Institution, Saint-Lambert,  Quebec,  Canada; Recruiting
      Local Institution, Chicoutimi,  Quebec,  Canada; Recruiting
      Local Institution, Drummondville,  Quebec,  Canada; Recruiting
      Local Institution, Montreal,  Quebec,  Canada; Recruiting
      Local Institution, Ste Foy,  Quebec,  Canada; Recruiting
Canada, Saskatchewan
      Local Institution, Saskatoon,  Saskatchewan,  Canada; Recruiting
France
      Local Institution, Ambrieres Les Vallees,  France; No longer recruiting
      Local Institution, Angers,  France; No longer recruiting
      Local Institution, Bagneux,  France; No longer recruiting
      Local Institution, Bouere,  France; No longer recruiting
      Local Institution, Chateau-Gontier,  France; No longer recruiting
      Local Institution, Cherbourg,  France; No longer recruiting
      Local Institution, Equeurdreville,  France; No longer recruiting
      Local Institution, Evron,  France; No longer recruiting
      Local Institution, La Glacerie,  France; No longer recruiting
      Local Institution, La Rochelle,  France; No longer recruiting
      Local Institution, Le Lion-d'Angers,  France; No longer recruiting
      Local Institution, Longue,  France; No longer recruiting
      Local Institution, Mayenne,  France; No longer recruiting
      Local Institution, Nieul-sur-Mer,  France; No longer recruiting
      Local Institution, Noyant,  France; No longer recruiting
      Local Institution, Sainte-Suzanne,  France; No longer recruiting
      Local Institution, Saumur,  France; No longer recruiting
      Local Institution, Villebernier,  France; No longer recruiting
      Local Institution, Laval,  France; No longer recruiting
      Local Institution, Louverne,  France; No longer recruiting
      Local Institution, Longue Jumelles,  France; No longer recruiting
Germany
      Local Institution, Berlin,  Germany; Not yet recruiting
      Local Institution, Blankenhain,  Germany; Recruiting
      Local Institution, ESSEN,  Germany; Recruiting
      Local Institution, Floersheim,  Germany; Recruiting
      Local Institution, Frankfurt,  Germany; Recruiting
      Local Institution, Fuerth,  Germany; Recruiting
      Local Institution, Georgsmarienhuette,  Germany; Recruiting
      Local Institution, Germersheim,  Germany; Recruiting
      Local Institution, Hamburg,  Germany; Recruiting
      Local Institution, Hannover,  Germany; Recruiting
      Local Institution, Krombach,  Germany; Not yet recruiting
      Local Institution, Lambrecht,  Germany; Recruiting
      Local Institution, Mainburg,  Germany; Recruiting
      Local Institution, Mannheim,  Germany; Not yet recruiting
      Local Institution, Messkirch,  Germany; Recruiting
      Local Institution, Monheim,  Germany; Recruiting
      Local Institution, Parsberg,  Germany; Recruiting
      Local Institution, Pforzheim,  Germany; Recruiting
      Local Institution, Stuttgart,  Germany; Recruiting
      Local Institution, Waldbrunn,  Germany; Recruiting
      Local Institution, Welver,  Germany; Recruiting
      Local Institution, Nuernberg,  Germany; Recruiting
      Local Institution, KUENZING,  Germany; Recruiting
      Local Institution, Beckum,  Germany; Recruiting
      Local Institution, Villingen-Schwenningen,  Germany; Recruiting
Germany, Baden-Wurttembe
      Local Institution, Spaichingen,  Baden-Wurttembe,  Germany; Recruiting
Germany, Niedersach
      Local Institution, Loxstedt,  Niedersach,  Germany; Recruiting
Israel
      Local Institution, Beer-Sheva,  Israel; Recruiting
      Local Institution, Haifa,  Israel; Recruiting
      Local Institution, Holon,  Israel; Recruiting
      Local Institution, Jerusalem,  Israel; Recruiting
      Local Institution, Kfar Saba,  Israel; Recruiting
      Local Institution, Matan,  Israel; Recruiting
      Local Institution, Tel Hashomer,  Israel; Not yet recruiting
      Local Institution, Zerifin,  Israel; Recruiting
Netherlands
      Local Institution, Beek En Donk,  Netherlands; Recruiting
      Local Institution, Eindhoven,  Netherlands; Recruiting
      Local Institution, Hardenberg,  Netherlands; Recruiting
      Local Institution, HEERLEN,  Netherlands; Recruiting
      Local Institution, Lichtenvoorde,  Netherlands; No longer recruiting
      Local Institution, Rijswyk Zh,  Netherlands; Recruiting
      Local Institution, S. Gravenhage,  Netherlands; Recruiting
      Local Institution, Tilburg,  Netherlands; No longer recruiting
      Local Institution, Venlo,  Netherlands; Recruiting
      Local Institution, Waalwijk,  Netherlands; Recruiting
      Local Institution, Woerden,  Netherlands; Recruiting
      Local Institution, Zeist,  Netherlands; Recruiting
Russian Federation
      Local Institution, Moscow,  Russian Federation; Recruiting
      Local Institution, St Petersburg,  Russian Federation; Recruiting
      Local Institution, SARATOV,  Russian Federation; Recruiting

Study ID Numbers:  CV131-176
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  November 3, 2004
ClinicalTrials.gov Identifier:  NCT00095394
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08