Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
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