study of efficacy and safety of irbesartan/amlodipine 4 fixed combination therapy in hypertensive patients uncontrolled on irbesartan or amlodipine monotherapy

Conditions: Hypertension

Summary: primary objective: - to assess the proportion of patients with controlled office blood pressure measurements (obpm), defined as systolic blood pressure \< 140 mmhg and diastolic blood pressure \<90mmhg, at the end of the study secondary objectives: * to examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on obpm (sbp (systolic blood pressure) and dbp (diastolic blood pressure) * to examine the proportion of patients with controlled obpm (systolic bp\<140 mm hg and diastolic bp\<90 mmhg) of the different dose groups over time * to determine the incidence and severity of adverse events.

16 weeks * v1 (week 0): inclusion visit. * v2 (week 4): irbesartan/amlodipine 150/5 mg fixed combination visit * v3 (week 8): 1st dose escalation for patients in whom obpm is not controlled (sbp ≥ 140 mmhg or dbp ≥ 90mmhg, * v4 (week 12): 2nd dose escalation visit for patients in whom obpm is not controlled (sbp ≥ 140 mmhg or dbp ≥ 90mmhg * v5 (week 16): end of study visit

Eligibility criteria:
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.