Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy (I-ADD)

NCT00957554 Phase 3 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	435
Start date	2009-07
Completion	2010-09

Conditions

• Hypertension

Interventions

• irbesartan/amlodipine
• irbesartan

Primary outcomes

• Mean home systolic blood pressure — At randomisation and week 10

Countries

Brazil, Colombia, Guatemala, Mexico, Morocco, Tunisia, United Arab Emirates, Venezuela