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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
A2	Irbesartan monotherapy	-
A1	Irbesartan/HCTZ	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5

Secondary Outcome Measures

Name	Time	Method
Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.