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

NCT00095550 | Completed Phase 3

• 1 other identifier: CV131-185
• Study Type: interventional
• Target: 496
• Locations: 5 countries
• Sites: 128

Brief Summary

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.

Conditions

Hypertension

Keywords

Moderate Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in SeSBP at Week 8

Secondary Outcomes (1)

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

Study Arms (3)

A1

EXPERIMENTAL

Drug: Irbesartan/HCTZ

A2

ACTIVE COMPARATOR

Drug: Irbesartan monotherapy

A3

ACTIVE COMPARATOR

Drug: HCTZ monotherapy

Interventions

Irbesartan/HCTZ DRUG

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

Also known as: Avapro

A1

Irbesartan monotherapy DRUG

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

Also known as: Avapro

A2

HCTZ monotherapy DRUG

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

A3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Sanofi: collaborator

Study Sites (128)

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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MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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 5, 2004
• First Posted: November 8, 2004
• Study Start: October 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: April 15, 2011

Record last verified: 2008-08

Locations

CA (22); DE (12); RU (3); FR (4); US (87)