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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Irbesartan monotherapy

Drug: Irbesartan/HCTZ

Drug: HCTZ monotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095550

CV131-185

Details and patient eligibility

About

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.

Enrollment

496 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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