Hypertension Clinical Trial
Official title:
Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Primary Objective:
To demonstrate that the antihypertensive efficacy of the fixed combination
irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in
lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM)
after 10 weeks of treatment (W10)
Secondary Objective:
- To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine
300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)
- To compare the antihypertensive efficacy of the fixed combination therapy
irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks
of treatment (W5)
- 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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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