Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00095394

Run by

Bristol-Myers Squibb

People needed

645

Starts

2004-09-01

Expected to finish

2005-05-01

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…

• 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.

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 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.

Where it is running

• Local Institution — Columbiana, Alabama, United States
• Local Institution — Huntsville, Alabama, United States
• Local Institution — Mesa, Arizona, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Scottsdale, Arizona, United States
• Local Institution — Sherwood, Arkansas, United States
• Local Institution — 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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