The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and
300/25 mg in patients with hypertension not controlled by monotherapy.
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes,
metabolic syndrome and prior HTN therapy.
- The patient must have hypertension and uncontrolled SBP on monotherapy.
- Patients who have read, signed and received a copy of the informed consent prior to
any study procedures
Note: Female patients must be post-menopausal for one year, surgically sterilized, or
using a medically accepted method of contraception (intrauterine device, oral
contraceptives, barrier method with spermicide) and must agree to use an effective method
of contraception throughout the study.
- Any history of secondary hypertension
- History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA)
within the past 12 months
- History of myocardial infarction, percutaneous transluminal coronary
revascularization, coronary artery bypass graft, and/or unstable angina pectoris
within the past 6 months