HypertensionPhase 3NCT00095394

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

A Phase 3 study testing Irbesartan/HCTZ and Irbesartan monotherapy in people with Hypertension, run by Bristol-Myers Squibb at 269 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Irbesartan/HCTZ and Irbesartan monotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 645 participants
Where: 269 sitesin 8 countries
Study dates: Sep 2004to May 2005
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

269 sites in 8 countries.

Country

City, postcode or hospital

269 sites in 8 countries

United States156 sites

Local Institution
Albuquerque, New Mexico
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Atlanta, Georgia
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Austin, Texas
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Ayer, Massachusetts
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Baltimore, Maryland
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Bartlett, Tennessee
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Bensalem, Pennsylvania
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Birmingham, Alabama
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Boulder, Colorado
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Bridgeport, Connecticut
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Bristol, Tennessee
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Buffalo, New York
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Burke, Virginia
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Butte, Montana
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Camp Hill, Pennsylvania
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Canton, Ohio
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Carlsbad, California
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Carmichael, California
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Chalmette, Louisiana
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Charleston, South Carolina
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Charlotte, North Carolina
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Charlotte Harbour, Florida
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Charlottesville, Virginia
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Chicago, Illinois
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Chipley, Florida
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Mississippi
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Cocoa Beach, Florida
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Collegeville, Pennsylvania
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Colleyville, Texas
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Columbia, South Carolina
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Columbiana, Alabama
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Columbus, Ohio
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Cordova, Tennessee
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Corona, California
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Cranston, Rhode Island
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Crestview, Florida
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Dallas, Texas
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DeLand, Florida
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Denver, Colorado
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Des Moines, Iowa
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Dover, New Hampshire
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East Syracuse, New York
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Elkton, Maryland
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Encinitas, California
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Erlanger, Kentucky
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Eugene, Oregon
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Fresno, California
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Fulton, New York
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Gastonia, North Carolina
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Genoa, Ohio
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Greensboro, North Carolina
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Hampton, Virginia
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Hendersonville, Tennessee
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High Point, North Carolina
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Highlands Ranch, Colorado
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Hillsborough, New Jersey
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Hollywood, Florida
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Huntsville, Alabama
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Jacksonville, Florida
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Johnson City, Tennessee
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Jupiter, Florida
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Kansas City, Kansas
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Kettering, Ohio
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Lacey, Washington
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Laguna Hills, California
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Lake Jackson, Texas
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Lake Success, New York
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Landrum, South Carolina
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Las Vegas, Nevada
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Levittown, Pennsylvania
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Livonia, Michigan
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Long Beach, California
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Lyndhurst, Ohio
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Madison, Wisconsin
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Manchester, Missouri
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Medford, Oregon
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Mesa, Arizona
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Miami, Florida
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Midland, Texas
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Milwaukee, Wisconsin
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Mint Hill, North Carolina
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Mission Hills, California
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Missoula, Montana
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Morristown, Tennessee
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Mount Vernon, New York
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Nashville, North Carolina
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Nashville, Tennessee
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New Orleans, Louisiana
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New Tazewell, Tennessee
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New York, New York
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Newark, Delaware
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Niceville, Florida
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Norfolk, Virginia
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North Miami Beach, Florida
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Ocala, Florida
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Ocoee, Florida
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Oklahoma City, Oklahoma
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Olean, New York
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Olive Branch, Mississippi
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Olympia, Washington
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Omaha, Nebraska
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Orangeburg, Oregon
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Oxon Hill, Maryland
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Pembroke Pines, Florida
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Penndel, Pennsylvania
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Peoria, Illinois
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Perrysburg, Ohio
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Picayune, Mississippi
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Port Orange, Florida
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Portland, Oregon
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Prosperity, South Carolina
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Raleigh, California
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Redondo Beach, California
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Richmond, Kentucky
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Rolling Hills Estate, California
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Roseville, California
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Sacramento, California
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Saginaw, Michigan
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Saint Cloud, Florida
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Salt Lake City, Utah
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Saluda, South Carolina
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San Antonio, Texas
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San Diego, California
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San Jose, California
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Santa Ana, California
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Sarasota, Florida
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Scottsdale, Arizona
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Selmer, Tennessee
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Sherwood, Arkansas
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Simpsonville, South Carolina
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South Bound Brook, New Jersey
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Spokane, Washington
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Springfield, Massachusetts
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St Louis, Missouri
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Sudbury, Massachusetts
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Summerville, South Carolina
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Tamarac, Florida
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Tampa, Florida
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The Bronx, New York
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The Colony, Texas
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Torrance, California
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Tulsa, Oklahoma
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Tustin, California
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Vernon Hills, Illinois
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Vero Beach, Florida
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Waterbury, Connecticut
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West Grove, Pennsylvania
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Wheat Ridge, Colorado
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Wichita, Kansas
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Wilmington, North Carolina
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Winston-Salem, North Carolina
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Zephyrhills, Florida

Other trials in United States

Canada32 sites

Local Institution
Aylmer, Ontario
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Bonaventure, Quebec
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Burlington, Ontario
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Chandler, Quebec
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Chicoutimi, Quebec
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Coquitlam, British Columbia
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Drummondville, Quebec
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Edmonton, Alberta
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Hamilton, Ontario
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London, Ontario
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Markham, Ontario
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Montague, Prince Edward Island
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Montreal, Quebec
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Niagra Falls, Ontario
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North Vancouver, British Columbia
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Oakville, Ontario
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Oshawa, Ontario
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Quesnel, British Columbia
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Red Deer, Alberta
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Richmond Hill, Ontario
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Saint-Lambert, Quebec
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Sarnia, Ontario
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Saskatoon, Saskatchewan
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Sidney, British Columbia
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St. John's, Newfoundland and Labrador
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Ste-Foy, Quebec
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Thornhill, Ontario
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Toronto, Ontario
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Windsor, Ontario
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Winnipeg, Manitoba

Other trials in Canada

Germany27 sites

Local Institution
Beckum
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Berlin
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Blankenhain
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Essen
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Flörsheim
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Frankfurt
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Fürth
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Georgsmarienhütte
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Germersheim
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Hamburg
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Hanover
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Krombach
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Künzing
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Lambrecht
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Loxstedt, Niedersach
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Mainburg
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Mannheim
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Messkirch
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Monheim
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Nuremberg
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Parsberg
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Pforzheim
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Spaichingen, Baden-Wurttembe
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Stuttgart
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Villingen-Schwenningen
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Waldbrunn
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Welver

Other trials in Germany

France21 sites

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Ambrières-les-Vallées
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Angers
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Bagneux
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Bouère
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Château-Gontier
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Cherbourg
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Équeurdreville-Hainneville
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Évron
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La Glacerie
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La Rochelle
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Laval
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Le Lion-dAngers
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Longue
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Longué-Jumelles
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Louverné
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Mayenne
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Nieul-sur-Mer
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Noyant
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Sainte-Suzanne
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Saumur
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Villebernier

Other trials in France

Netherlands12 sites

Local Institution
Beek en Donk
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Eindhoven
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Hardenberg
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Heerlen
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Lichtenvoorde
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Rijswyk Zh
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The Hague
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Tilburg
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Venlo
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Waalwijk
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Woerden
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Zeist

Other trials in Netherlands

Belgium10 sites

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Antwerp
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Brussels
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Edegem
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Genk
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Hasselt
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Huy, Luik
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La Louvière
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Liège
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Roeselare
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Wilrijk

Other trials in Belgium

Israel8 sites

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Beersheba
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Haifa
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Holon
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Jerusalem
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Kfar Saba
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Matan
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Tel HaShomer
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Tsrifin

Other trials in Israel

Russia3 sites

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Moscow
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Saint Petersburg
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Saratov

Other trials in Russia

About this study

Official title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension

Conditions: Hypertension
Being tested: Irbesartan/HCTZ, Irbesartan monotherapy
Keywords: Severe Hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Irbesartan/HCTZDrug
Also called Avapro
Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
Irbesartan monotherapyDrug
Also called Avapro
Tablets, Oral, 150 mg, Once daily, 7 weeks.

Study groups in NCT00095394
Study group	Role	What they receive
A1	Experimental	Not described Receives: Drug: Irbesartan/HCTZ
A2	Active comparator	Not described Receives: Drug: Irbesartan monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5

Secondary outcomes (1)

Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2004May 2005

First posted4 Nov 2004 (estimated)
Study startSep 2004
Primary completionMay 2005
Study completionMay 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 645 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00095394
Sponsor's protocol ID: CV131-176
Status last verified: Aug 2008
First submitted: 3 Nov 2004
Last updated: 15 Apr 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
ClinicalTrials.gov ID: NCT00095394
Acronym / sponsor ID: CV131-176
Conditions: Hypertension
Keywords: Severe Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 645 participants (estimated)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: Sep 2004
Primary completion: May 2005 (actual)
Study completion: May 2005 (actual)
First posted: 4 Nov 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A1	Experimental	Drug: Irbesartan/HCTZ
A2	Active comparator	Drug: Irbesartan monotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Irbesartan/HCTZAlso: AvaproTablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.	Drug	A1
Irbesartan monotherapyAlso: AvaproTablets, Oral, 150 mg, Once daily, 7 weeks.	Drug	A2

Primary outcome

Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5

1 secondary outcome

Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.

Related trials for Hypertension

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

269 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irbesartan/HCTZ and Irbesartan monotherapy in people with Hypertension, run by Bristol-Myers Squibb at 269 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, Canada, Germany, France, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.