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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Irbesartan/HCTZ; Drug: Irbesartan monotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 645
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A2	Drug: Irbesartan monotherapy; Tablets, Oral, 150 mg, Once daily, 7 weeks.; Other Names: Avapro
Experimental: A1	Drug: Irbesartan/HCTZ; Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.; Other Names: Avapro

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: November 3, 2004
• First Submitted That Met QC Criteria: November 3, 2004
• First Posted (Estimate): November 4, 2004

Study Record Updates

• Last Update Posted (Estimate): April 15, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Severe Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: CV131-176