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

NCT ID: NCT00095394

Last Updated: 2011-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 645 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A1

Group Type: EXPERIMENTAL

Irbesartan/HCTZ

Intervention Type: DRUG

Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.

A2

Group Type: ACTIVE_COMPARATOR

Irbesartan monotherapy

Intervention Type: DRUG

Tablets, Oral, 150 mg, Once daily, 7 weeks.

Interventions

Irbesartan/HCTZ

Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.

Intervention Type: DRUG

Irbesartan monotherapy

Tablets, Oral, 150 mg, Once daily, 7 weeks.

Intervention Type: DRUG

Other Intervention Names

Avapro; Avapro

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

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

Countries

United States; Belgium; Canada; France; Germany; Israel; Netherlands; Russia

Other Identifiers

CV131-176

Identifier Type: -

Identifier Source: org_study_id