Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy (I-COMBINE)

NCT00956644 Phase 3 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	406
Start date	2009-07
Completion	2010-08

Conditions

• Hypertension

Interventions

• irbesartan/amlodipine
• amlodipine

Primary outcomes

• Mean home systolic blood pressure — At randomisation and week 5

Countries

Brazil, Chile, Colombia, Egypt, Lebanon, Mexico, Morocco, Tunisia, Venezuela