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

A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy

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

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.