Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
1 other identifier
interventional
645
8 countries
269
Brief 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. In addition, the study will also evaluate the safety and tolerability of the drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Sep 2004
Shorter than P25 for phase_3 hypertension
269 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2004
CompletedFirst Posted
Study publicly available on registry
November 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedApril 15, 2011
August 1, 2008
8 months
November 3, 2004
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
A1
EXPERIMENTALA2
ACTIVE COMPARATORInterventions
Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Sanoficollaborator
Study Sites (269)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Huntsville, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Sherwood, Arkansas, United States
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Carlsbad, California, United States
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Carmichael, California, United States
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Corona, California, United States
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Encinitas, California, United States
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Fresno, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Mission Hills, California, United States
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Raleigh, California, United States
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Redondo Beach, California, United States
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Rolling Hills Estate, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Highlands Ranch, Colorado, United States
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Wheat Ridge, Colorado, United States
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Bridgeport, Connecticut, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Charlotte Harbour, Florida, United States
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Chipley, Florida, United States
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Clearwater, Florida, United States
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Cocoa Beach, Florida, United States
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Crestview, Florida, United States
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DeLand, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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Niceville, Florida, United States
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North Miami Beach, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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Saint Cloud, Florida, United States
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Sarasota, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Vernon Hills, Illinois, United States
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Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Erlanger, Kentucky, United States
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Richmond, Kentucky, United States
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Chalmette, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Elkton, Maryland, United States
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Oxon Hill, Maryland, United States
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Ayer, Massachusetts, United States
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Springfield, Massachusetts, United States
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Sudbury, Massachusetts, United States
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Livonia, Michigan, United States
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Saginaw, Michigan, United States
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Cleveland, Mississippi, United States
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Olive Branch, Mississippi, United States
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Picayune, Mississippi, United States
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Manchester, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Dover, New Hampshire, United States
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Hillsborough, New Jersey, United States
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South Bound Brook, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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East Syracuse, New York, United States
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Fulton, New York, United States
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Lake Success, New York, United States
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Mount Vernon, New York, United States
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New York, New York, United States
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Olean, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, United States
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Mint Hill, North Carolina, United States
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Nashville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Genoa, Ohio, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Orangeburg, Oregon, United States
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Portland, Oregon, United States
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Bensalem, Pennsylvania, United States
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Camp Hill, Pennsylvania, United States
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Collegeville, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Penndel, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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West Grove, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Landrum, South Carolina, United States
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Prosperity, South Carolina, United States
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Saluda, South Carolina, United States
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Simpsonville, South Carolina, United States
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Summerville, South Carolina, United States
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Bartlett, Tennessee, United States
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Bristol, Tennessee, United States
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Cordova, Tennessee, United States
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Hendersonville, Tennessee, United States
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Johnson City, Tennessee, United States
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Morristown, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Selmer, Tennessee, United States
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Austin, Texas, United States
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Colleyville, Texas, United States
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Dallas, Texas, United States
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Lake Jackson, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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The Colony, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Charlottesville, Virginia, United States
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Hampton, Virginia, United States
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Norfolk, Virginia, United States
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Lacey, Washington, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Huy, Luik, Belgium
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Antwerp, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Genk, Belgium
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Hasselt, Belgium
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La Louvière, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Wilrijk, Belgium
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Edmonton, Alberta, Canada
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Red Deer, Alberta, Canada
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Coquitlam, British Columbia, Canada
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North Vancouver, British Columbia, Canada
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Quesnel, British Columbia, Canada
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Sidney, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Aylmer, Ontario, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Niagra Falls, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Sarnia, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montague, Prince Edward Island, Canada
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Bonaventure, Quebec, Canada
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Chandler, Quebec, Canada
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Chicoutimi, Quebec, Canada
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Drummondville, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Ambrières-les-Vallées, France
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Angers, France
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Bagneux, France
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Bouère, France
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Château-Gontier, France
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Cherbourg, France
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Équeurdreville-Hainneville, France
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Évron, France
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La Glacerie, France
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La Rochelle, France
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Laval, France
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Le Lion-dAngers, France
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Longue, France
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Longué-Jumelles, France
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Louverné, France
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Mayenne, France
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Nieul-sur-Mer, France
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Noyant, France
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Sainte-Suzanne, France
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Saumur, France
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Villebernier, France
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Spaichingen, Baden-Wurttembe, Germany
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Loxstedt, Niedersach, Germany
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Beckum, Germany
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Berlin, Germany
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Blankenhain, Germany
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Essen, Germany
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Flörsheim, Germany
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Frankfurt, Germany
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Fürth, Germany
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Georgsmarienhütte, Germany
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Germersheim, Germany
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Hamburg, Germany
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Hanover, Germany
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Krombach, Germany
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Künzing, Germany
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Lambrecht, Germany
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Mainburg, Germany
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Mannheim, Germany
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Messkirch, Germany
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Monheim, Germany
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Nuremberg, Germany
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Parsberg, Germany
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Pforzheim, Germany
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Stuttgart, Germany
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Villingen-Schwenningen, Germany
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Waldbrunn, Germany
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Welver, Germany
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Beersheba, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Matan, Israel
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Tel Litwinsky, Israel
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Ẕerifin, Israel
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Beek en Donk, Netherlands
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Eindhoven, Netherlands
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Hardenberg, Netherlands
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Heerlen, Netherlands
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Lichtenvoorde, Netherlands
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Rijswyk Zh, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Venlo, Netherlands
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Waalwijk, Netherlands
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Woerden, Netherlands
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Zeist, Netherlands
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 3, 2004
First Posted
November 4, 2004
Study Start
September 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
April 15, 2011
Record last verified: 2008-08