None listed
Conditions
Interventions
Group 1 Type of group
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks
Group name:Group 2 Type of group
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Men and women> 18 years old • Essential hypertension established • Treated with amlodipine 5 mg monotherapy for at least 4 weeks • With uncontrolled blood pressure defined as mean SBP> 145 mmHg evaluated by OBPM • Signed informed consent obtained before inclusion in the study
Exclusion criteria
Exclusion criteria: • Average SBP> 180 mmHg and / or average DBP> 110 mmHg measured in the doctor´s office at Visit 1 • Known or suspected causes of secondary hypertension • Patients with bilateral arterial stenosis, renal artery stenosis in a solitary kidney, renal transplant or only a functioning kidney • Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination of both medications or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of medications used. • Type 1 diabetes known • Known severe hepatic impairment [alanine aminotransferase (ALT) or aspaitan aminotransferase (AST)> 5 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval derivation] • Known severe renal impairment (creatinine clearance <30 ml / mn) • Concomitant use of any antihypertensive treatment • Administration of any other investigative medication within 30 days prior to inclusion • Inability to obtain a valid automatic blood pressure measurement record • Presence of any severe medical or psychological condition that, in the opinion of the researcher, indicates that participation in the study is not in the best interest of the patient • Presence of any condition (eg geographic, social, etc.) that could restrict or limit patient participation for the duration of the study • Pregnant or breastfeeding women • Women with the potential to conceive children who are incapable or who do not wish to use an acceptable method to prevent pregnancy during the entire study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It will be based on the measurements made by the patient in the last 7 days of each measurement period. The measurements of the morning and afternoon of the first day of each measurement period will be discontinued in this criterion since these will be considered a training. The primary criteria will be calculated based on the average of all available measurements (4 measurements per day for 6 days). This average will be computed only if a minimum of 12 correct measurements are recorded during the last 6 days of each measurement period. Measure:Mean home systolic blood pressure Timepoints:At randomisation and week 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The average SBP of the office and the average DBP of the office will be calculated based on the number of available measurements assuming that at least one of the measurements is available Measure:Mean office blood pressure Timepoints:At randomisation, week 5 and week 10 ; Outcome name:DBP at home will be calculated as for the SBP at home Measure:Mean home diastolic blood pressure Timepoints:At randomisation, week 5 and week 10 | — |
Countries
Arabia Saudi, Argeria, Brazil, Chile, Colombia, Egypt, Lebano, Mauritius, Morocco, Peru, Tunisia, Venezuela
Outcome results
None listed