Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

Inclusion criteria:

• Established essential hypertension

• Treated with amlodipine 5 mg monotherapy for at least 4 weeks

• With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM

• Signed written inform consent obtained prior to inclusion in the study Randomisation Criteria:

• Mean SBP = or > 135 mmHg assessed by HBPM

• Good compliance with the HBPM protocol defined as at least 12 correct measurementsperformed over the last 6 days of the first period of measurements

• Creatinine clearance = or > 30 ml/min, determined by Cockroft formula

Exclusion criteria:

• Mean SBP = or > 180 mm Hg and/or mean DBP = or > 110 mm Hg measured at doctor's officeat Visit 1

• Known or suspected causes of secondary hypertension

• Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney,renal transplant or only one functioning kidney

• Know contraindications or hypersensitivity to either amlodipine or irbesartan or tothe combination or history of angioedema related to the administration of anangiotensin II receptor antagonist or any combination of the drugs used

• Known type 1 diabetes

• Know severe hepatic impairment alanine aminotransferase (ALT) or aspartateaminotransferase (AST) > 5 times the upper limit of normal or history or hepaticencephalopathy, esophageal varices, or portocaval shunt

• Known severe renal impairment (creatinine clearance < 30 ml/mn)

• Concomitant use of any other antihypertensive treatment

• Administration of any other investigational drug within 30 days before inclusion

• Inability to obtain a valid automatic BP measurement recording

• Presence of any severe medical or psychological condition that, in the opinion of theinvestigator, indicate that participation in the study is not in the best interest ofthe patient

• Presence of any other conditions (e.g.: geographical, social, etc) that would restrictor limit the patient participation for the duration of the study

• Pregnant or breast feeding women

• Women of childbearing potential unable or unwilling to use an acceptable method toavoid pregnancy for the entire study period The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.