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

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00562809

Run by

Sanofi

People needed

1005

Starts

2003-07-01

Expected to finish

2004-08-01

Last updated by the study team

2007-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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