Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Inclusion criteria : * Men and women ≥18 years old * Established essential hypertension * Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks * With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements) * Signed written informed consent obtained prior to inclusion to the study Exclusion criteria: * Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on 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 has one functioning kidney * Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination * History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used * Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt) * Severe renal impairment (glomerular filtration rate \<30 ml/min) * Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine * Administration of any other investigational drug within 30 days before inclusion * Presence of any other conditions that would restrict or 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 to avoid pregnancy for the entire study period * Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.