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

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00095550

Run by

Bristol-Myers Squibb

People needed

496

Starts

2004-10-01

Expected to finish

2005-06-01

Last updated by the study team

2011-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Local Institution — Columbiana, Alabama, United States
• Local Institution — Mesa, Arizona, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — 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 — Highlands Ranch, Colorado, United States
• Local Institution — Bridgeport, Connecticut, United States
• Local Institution — Waterbury, Connecticut, United States
• Local Institution — Newark, Delaware, 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 — Miami, Florida, United States
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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