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.

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:

• Willing to provide written informed consent
• Subjects must have uncontrolled hypertension defined as: *average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or *average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
• 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:

• 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 six months.
• Significant kidney disease
• Significant liver disease
• Systemic lupus erythematosus
• Gastrointestinal disease or surgery that 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. 149 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 149 

Alabama
      Local Institution, Birmingham,  Alabama,  United States; Recruiting
      Local Institution, Columbiana,  Alabama,  United States; Recruiting
Arizona
      Local Institution, Mesa,  Arizona,  United States; Not yet recruiting
      Local Institution, Phoenix,  Arizona,  United States; Recruiting
California
      Local Institution, Fresno,  California,  United States; Recruiting
      Local Institution, Long Beach,  California,  United States; Recruiting
      Local Institution, Rolling Hills Estate,  California,  United States; Recruiting
      Local Institution, Roseville,  California,  United States; Recruiting
      Local Institution, Sacramento,  California,  United States; Recruiting
      Local Institution, San Jose,  California,  United States; Recruiting
      Local Institution, Torrance,  California,  United States; Recruiting
      Local Institution, Tustin,  California,  United States; Recruiting
      Local Institution, Fair Oaks,  California,  United States; No longer recruiting
      Local Institution, Carmichael,  California,  United States; Recruiting
Colorado
      Local Institution, Highlands Ranch,  Colorado,  United States; Recruiting
Connecticut
      Local Institution, Waterbury,  Connecticut,  United States; Recruiting
      Local Institution, Bridgeport,  Connecticut,  United States; Recruiting
Delaware
      Local Institution, Newark,  Delaware,  United States; Recruiting
Florida
      Local Institution, Chipley,  Florida,  United States; Recruiting
      Local Institution, Clearwater,  Florida,  United States; Recruiting
      Local Institution, Crestview,  Florida,  United States; Recruiting
      Local Institution, Deland,  Florida,  United States; Recruiting
      Local Institution, Hollywood,  Florida,  United States; Recruiting
      Local Institution, Jacksonville,  Florida,  United States; Recruiting
      Local Institution, Niceville,  Florida,  United States; Recruiting
      Local Institution, Ocoee,  Florida,  United States; Recruiting
      Local Institution, Pembroke Pines,  Florida,  United States; Recruiting
      Local Institution, St. Cloud,  Florida,  United States; Recruiting
      Local Institution, Miami,  Florida,  United States; Recruiting
Georgia
      Local Institution, Atlanta,  Georgia,  United States; Recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Recruiting
      Local Institution, Peoria,  Illinois,  United States; 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
Massachusetts
      Local Institution, Springfield,  Massachusetts,  United States; Recruiting
Michigan
      Local Institution, Livonia,  Michigan,  United States; Recruiting
      Local Institution, Saginaw,  Michigan,  United States; Recruiting
Mississippi
      Local Institution, Olive Branch,  Mississippi,  United States; Recruiting
Montana
      Local Institution, Missoula,  Montana,  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
New York
      Local Institution, Bronx,  New York,  United States; Recruiting
      Local Institution, Buffalo,  New York,  United States; Recruiting
      Local Institution, Mt. Vernon,  New York,  United States; Recruiting
      Local Institution, New York,  New York,  United States; No longer recruiting
North Carolina
      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, Mint Hill,  North Carolina,  United States; Recruiting
      Local Institution, Winston Salem,  North Carolina,  United States; Recruiting
Ohio
      Local Institution, Canton,  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, Lyndhurst,  Ohio,  United States; Recruiting
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States; Recruiting
Oregon
      Local Institution, Eugene,  Oregon,  United States; Recruiting
      Local Institution, Medford,  Oregon,  United States; Recruiting
      Local Institution, Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Local Institution, Bensalem,  Pennsylvania,  United States; Recruiting
      Local Institution, Camp Hill,  Pennsylvania,  United States; Recruiting
      Local Institution, Collegeville,  Pennsylvania,  United States; Recruiting
      Local Institution, Levittown,  Pennsylvania,  United States; Recruiting
      Local Institution, Penndel,  Pennsylvania,  United States; Recruiting
      Local Institution, Philadelphia,  Pennsylvania,  United States; Recruiting
      Local Institution, West Grove,  Pennsylvania,  United States; Recruiting
South Carolina
      Local Institution, Charleston,  South Carolina,  United States; Recruiting
      Local Institution, Columbia,  South Carolina,  United States; Recruiting
      Local Institution, Orangeburg,  South Carolina,  United States; Recruiting
      Local Institution, Simpsonville,  South Carolina,  United States; Recruiting
      Local Institution, Summerville,  South Carolina,  United States; Recruiting
Tennessee
      Local Institution, Bartlett,  Tennessee,  United States; Recruiting
      Local Institution, Hendersonville,  Tennessee,  United States; Recruiting
      Local Institution, Nashville,  Tennessee,  United States; Recruiting
      Local Institution, Selmer,  Tennessee,  United States; Recruiting
Texas
      Local Institution, Austin,  Texas,  United States; Recruiting
      Local Institution, Colleyville,  Texas,  United States; Recruiting
      Local Institution, Midland,  Texas,  United States; Recruiting
      Local Institution, San Antonio,  Texas,  United States; Recruiting
Utah
      Local Institution, Salt Lake City,  Utah,  United States; No longer recruiting
Virginia
      Local Institution, Charlottesville,  Virginia,  United States; Recruiting
Washington
      Local Institution, Olympia,  Washington,  United States; Recruiting
      Local Institution, Spokane,  Washington,  United States; Recruiting
Wisconsin
      Local Institution, Madison,  Wisconsin,  United States; Recruiting
      Local Institution, Milwaukee,  Wisconsin,  United States; Recruiting
Canada, Alberta
      Local Institution, Red Deer,  Alberta,  Canada; Recruiting
Canada, British Columbia
      Local Institution, Coquitlam,  British Columbia,  Canada; Recruiting
      Local Institution, North Vancouver,  British Columbia,  Canada; Recruiting
      Local Institution, Sidney,  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, Aylmer,  Ontario,  Canada; Recruiting
      Local Institution, Burlington,  Ontario,  Canada; Recruiting
      Local Institution, Hamilton,  Ontario,  Canada; Recruiting
      Local Institution, Markham,  Ontario,  Canada; Recruiting
      Local Institution, Oakville,  Ontario,  Canada; Recruiting
      Local Institution, Oshawa,  Ontario,  Canada; Recruiting
      Local Institution, Richmond Hill,  Ontario,  Canada; Recruiting
      Local Institution, Sarnia,  Ontario,  Canada; Recruiting
      Local Institution, Thornhill,  Ontario,  Canada; Recruiting
      Local Institution, Toronto,  Ontario,  Canada; Recruiting
Canada, Prince Edward Island
      Local Institution, Montague,  Prince Edward Island,  Canada; Recruiting
Canada, Quebec
      Local Institution, Drummondville,  Quebec,  Canada; Recruiting
      Local Institution, Greenfield Park,  Quebec,  Canada; Recruiting
      Local Institution, St-Lambert,  Quebec,  Canada; Recruiting
Canada, Saskatchewan
      Local Institution, Saskatoon,  Saskatchewan,  Canada; Recruiting
France
      Local Institution, Angers,  France; No longer recruiting
      Local Institution, Bouchemaine,  France; No longer recruiting
      Local Institution, Briollay,  France; No longer recruiting
      Local Institution, Tierce,  France; No longer recruiting
Germany
      Local Institution, Berlin,  Germany; Recruiting
      Local Institution, FELDAFING,  Germany; Recruiting
      Local Institution, GROEMITZ,  Germany; Recruiting
      Local Institution, KUENZING,  Germany; Recruiting
      Local Institution, Noerten-Hardenberg,  Germany; Recruiting
      Local Institution, Nuernberg,  Germany; Recruiting
      Local Institution, ORNBAU,  Germany; Recruiting
      Local Institution, Unterschneidheim,  Germany; Recruiting
      Local Institution, Villingen-Schwenningen,  Germany; Recruiting
      Local Institution, ESSEN,  Germany; Recruiting
Germany, Baden-Wurttembe
      Local Institution, Spaichingen,  Baden-Wurttembe,  Germany; Recruiting
Germany, Braden-Wurttembe
      Local Institution, Spaichingen,  Braden-Wurttembe,  Germany; Recruiting
Russian Federation
      Local Institution, Moscow,  Russian Federation; Not yet recruiting
      Local Institution, St Petersburg,  Russian Federation; Not yet recruiting
      Local Institution, SARATOV,  Russian Federation; Not yet recruiting

Study ID Numbers:  CV131-185
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095550
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08