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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan

Criteria

Inclusion Criteria:

• 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.

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 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.