The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

Sanofi

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: IRBESARTAN

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562809

L_8829

Details and patient eligibility

About

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.

Full description

The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.

Enrollment

1,005 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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