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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amlodipine; Irbesartan

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.