Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 measurements performed over the last 6 days of the first period of measurements
Creatinine clearance = or \> 30 ml/min, determined by Cockroft formula
You may not be if
Mean SBP = or \> 180 mm Hg and/or mean DBP = or \> 110 mm Hg measured at doctor's office at 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 to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
Known type 1 diabetes
Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal or history or hepatic encephalopathy, 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 the investigator, indicate that participation in the study is not in the best interest of the patient
Presence of any other conditions (e.g.: geographical, social, etc) 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
