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

NCT ID: NCT00095550

Last Updated: 2011-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

Irbesartan/HCTZ

Intervention Type DRUG

Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.

A2

Group Type ACTIVE_COMPARATOR

Irbesartan monotherapy

Intervention Type DRUG

Tablets, Oral, 150 mg, Once daily, 12 weeks.

A3

Group Type ACTIVE_COMPARATOR

HCTZ monotherapy

Intervention Type DRUG

Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

Interventions

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Irbesartan/HCTZ

Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.

Intervention Type DRUG

Irbesartan monotherapy

Tablets, Oral, 150 mg, Once daily, 12 weeks.

Intervention Type DRUG

HCTZ monotherapy

Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Avapro Avapro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Carmichael, California, United States

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Fair Oaks, California, United States

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Fresno, California, United States

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Long 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 Jose, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Highlands Ranch, 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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Chipley, Florida, United States

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Clearwater, 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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Miami, Florida, United States

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Niceville, Florida, United States

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Ocoee, Florida, United States

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Pembroke Pines, Florida, United States

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Saint Cloud, 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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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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Oxon Hill, Maryland, United States

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Springfield, Massachusetts, United States

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Livonia, Michigan, United States

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Saginaw, Michigan, United States

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Olive Branch, Mississippi, United States

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Missoula, Montana, United States

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Dover, New Hampshire, United States

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South Bound Brook, New Jersey, United States

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Buffalo, 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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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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Mint Hill, 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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Genoa, Ohio, United States

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Kettering, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, 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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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Orangeburg, 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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Hendersonville, Tennessee, United States

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Nashville, 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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Midland, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, 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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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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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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Markham, 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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Montague, Prince Edward Island, Canada

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Drummondville, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Angers, , France

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Bouchemaine, , France

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Briollay, , France

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Tiercé, , France

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Spaichingen, Baden-Wurttembe, Germany

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Spaichingen, Braden-Wurttembe, Germany

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Berlin, , Germany

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Essen, , Germany

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Feldafing, , Germany

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Grömitz, , Germany

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Künzing, , Germany

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Nörten-Hardenberg, , Germany

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Nuremberg, , Germany

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Ornbau, , Germany

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Unterschneidheim, , Germany

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Villingen-Schwenningen, , Germany

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Countries

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United States Canada France Germany Russia

Other Identifiers

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CV131-185

Identifier Type: -

Identifier Source: org_study_id

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