Primary Objective: * To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5) Secondary Objective: * To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5) * To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10) * To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM) * To determine the incidence and severity of adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
Sanofi-Aventis Investigational Site Number 07602
Campinas, Brazil
Sanofi-Aventis Investigational Site Number 076-005
Rio de Janeiro, Brazil
Sanofi-Aventis Investigational Site Number 07605
Rio de Janeiro, Brazil
Sanofi-Aventis Investigational Site Number 07604
São José, Brazil
Sanofi-Aventis Investigational Site Number 07601
São Paulo, Brazil
Mean home systolic blood pressure
Time frame: At randomisation and week 5
Mean office blood pressure
Time frame: At randomisation, week 5 and week 10
Mean home diastolic blood pressure
Time frame: At randomisation, week 5 and week 10
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Sanofi-Aventis Investigational Site Number 076-004
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076-002
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 07603
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 15202
Santiago, Chile
Sanofi-Aventis Investigational Site Number 15203
Santiago, Chile
...and 30 more locations