Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension

The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 496
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Red Deer, Alberta, Canada
      • Local Institution
  • British Columbia
    • Coquitlam, British Columbia, Canada
      • Local Institution
    • North Vancouver, 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
    • Markham, 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
  • Prince Edward Island
    • Montague, Prince Edward Island, Canada
      • Local Institution
  • Quebec
    • Drummondville, Quebec, Canada
      • Local Institution
    • Greenfield Park, Quebec, Canada
      • Local Institution
    • St. Lambert, Quebec, Canada
      • Local Institution
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Local Institution
• France
  • Angers, France
    • Local Institution
  • Bouchemaine, France
    • Local Institution
  • Briollay, France
    • Local Institution
  • Tierce, France
    • Local Institution
• Germany
  • Berlin, Germany
    • Local Institution
  • Essen, Germany
    • Local Institution
  • Feldafing, Germany
    • Local Institution
  • Groemitz, Germany
    • Local Institution
  • Kuenzing, Germany
    • Local Institution
  • Noerten-hardenberg, Germany
    • Local Institution
  • Nuernberg, Germany
    • Local Institution
  • Ornbau, Germany
    • Local Institution
  • Unterschneidheim, Germany
    • Local Institution
  • Villingen-schwenningen, Germany
    • Local Institution
  • Baden-Wurttembe
    • Spaichingen, Baden-Wurttembe, Germany
      • Local Institution
  • Braden-Wurttembe
    • Spaichingen, Braden-Wurttembe, Germany
      • 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
  • Arizona
    • Mesa, Arizona, United States
      • Local Institution
    • Phoenix, Arizona, United States
      • Local Institution
  • California
    • Carmichael, California, United States
      • Local Institution
    • Fair Oaks, California, United States
      • Local Institution
    • Fresno, California, United States
      • Local Institution
    • Long 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 Jose, California, United States
      • Local Institution
    • Torrance, California, United States
      • Local Institution
    • Tustin, California, United States
      • Local Institution
  • Colorado
    • Highlands Ranch, 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
    • 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
    • Miami, Florida, United States
      • Local Institution
    • Niceville, Florida, United States
      • Local Institution
    • Ocoee, Florida, United States
      • Local Institution
    • Pembroke Pines, Florida, United States
      • Local Institution
    • St. Cloud, 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
  • Louisiana
    • Chalmette, Louisiana, United States
      • Local Institution
    • New Orleans, Louisiana, United States
      • Local Institution
  • Maryland
    • Baltimore, Maryland, United States
      • Local Institution
    • Oxon Hill, Maryland, United States
      • Local Institution
  • Massachusetts
    • Springfield, Massachusetts, United States
      • Local Institution
  • Michigan
    • Livonia, Michigan, United States
      • Local Institution
    • Saginaw, Michigan, United States
      • Local Institution
  • Mississippi
    • Olive Branch, Mississippi, United States
      • Local Institution
  • Montana
    • Missoula, Montana, United States
      • Local Institution
  • New Hampshire
    • Dover, New Hampshire, United States
      • Local Institution
  • New Jersey
    • South Bound Brook, New Jersey, United States
      • Local Institution
  • New York
    • Bronx, New York, United States
      • Local Institution
    • Buffalo, New York, United States
      • Local Institution
    • Mt. Vernon, New York, United States
      • Local Institution
    • New York, 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
    • Mint Hill, 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
    • Genoa, Ohio, United States
      • Local Institution
    • Kettering, Ohio, United States
      • Local Institution
    • Lyndhurst, Ohio, United States
      • Local Institution
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Local Institution
  • Oregon
    • Eugene, Oregon, United States
      • Local Institution
    • Medford, 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
  • South Carolina
    • Charleston, South Carolina, United States
      • Local Institution
    • Columbia, South Carolina, United States
      • Local Institution
    • Orangeburg, 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
    • Hendersonville, Tennessee, United States
      • Local Institution
    • Nashville, Tennessee, United States
      • Local Institution
    • Selmer, Tennessee, United States
      • Local Institution
  • Texas
    • Austin, Texas, United States
      • Local Institution
    • Colleyville, Texas, United States
      • Local Institution
    • Midland, Texas, United States
      • Local Institution
    • San Antonio, Texas, United States
      • Local Institution
  • Utah
    • Salt Lake City, Utah, United States
      • Local Institution
  • Virginia
    • Charlottesville, Virginia, United States
      • Local Institution
  • Washington
    • 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:

• Willing to provide written informed consent

• Subjects must have uncontrolled hypertension defined as:

  • average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or
  • average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
• Subjects must be willing to discontinue their antihypertensive medication, if applicable.
• Men and women, ages 18 and older will be included.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Known or suspected secondary hypertension
• Hypertension emergencies or stroke within the past 12 months.
• Heart attack, angina or bypass surgery within the past six months.
• Significant kidney disease
• Significant liver disease
• Systemic lupus erythematosus
• Gastrointestinal disease or surgery that interfere with drug absorption
• Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin
• Currently pregnant or lactating
• Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Drug or alcohol abuse within the last five years
• Known allergy to irbesartan or diuretics

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A2	Drug: Irbesartan monotherapy; Tablets, Oral, 150 mg, Once daily, 12 weeks.; Other Names: Avapro
Experimental: A1	Drug: Irbesartan/HCTZ; Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.; Other Names: Avapro
Active Comparator: A3	Drug: HCTZ monotherapy; Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in SeSBP at Week 8

Secondary Outcome Measures

Outcome Measure
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: November 5, 2004
• First Submitted That Met QC Criteria: November 5, 2004
• First Posted (Estimate): November 8, 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: Moderate Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Irbesartan
• Other Study ID Numbers: CV131-185