Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
- Registration Number
- NCT00956644
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description irbesartan/amlodipine irbesartan/amlodipine Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks amlodipine amlodipine Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks
- Primary Outcome Measures
Name Time Method Mean home systolic blood pressure At randomisation and week 5
- Secondary Outcome Measures
Name Time Method Mean office blood pressure At randomisation, week 5 and week 10 Mean home diastolic blood pressure At randomisation, week 5 and week 10
Trial Locations
- Locations (40)
Sanofi-Aventis Investigational Site Number 17004
🇨🇴Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 15203
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 076-002
🇧🇷São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076-005
🇧🇷Rio de Janeiro, Brazil
Sanofi-Aventis Investigational Site Number 07602
🇧🇷Campinas, Brazil
Sanofi-Aventis Investigational Site Number 15202
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 076-004
🇧🇷São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 07605
🇧🇷Rio de Janeiro, Brazil
Sanofi-Aventis Investigational Site Number 15205
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 17003
🇨🇴Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 07601
🇧🇷São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 07603
🇧🇷São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 15204
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 15206
🇨🇱Santiago, Chile
Sanofi-Aventis Investigational Site Number 17002
🇨🇴Medellin, Colombia
Sanofi-Aventis Investigational Site Number 81801
🇪🇬Cairo, Egypt
Sanofi-Aventis Investigational Site Number 81802
🇪🇬Cairo, Egypt
Sanofi-Aventis Investigational Site Number 81803
🇪🇬Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 42202
🇱🇧Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 81804
🇪🇬Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 42205
🇱🇧Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 48401
🇲🇽Durango, Mexico
Sanofi-Aventis Investigational Site Number 48402
🇲🇽Guadalajara, Mexico
Sanofi-Aventis Investigational Site Number 42206
🇱🇧Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 48403
🇲🇽Guadalajara, Mexico
Sanofi-Aventis Investigational Site Number 48406
🇲🇽Guadalajara, Mexico
Sanofi-Aventis Investigational Site Number 50401
🇲🇦Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50402
🇲🇦Marrakech, Morocco
Sanofi-Aventis Investigational Site Number 50403
🇲🇦Marrakech, Morocco
Sanofi-Aventis Investigational Site Number 48404
🇲🇽Guadalajara, Mexico
Sanofi-Aventis Investigational Site Number 48405
🇲🇽Mexico, Mexico
Sanofi-Aventis Investigational Site Number 48407
🇲🇽Mexico, Mexico
Sanofi-Aventis Investigational Site Number 78804
🇹🇳Ariana, Tunisia
Sanofi-Aventis Investigational Site Number 78802
🇹🇳Sfax, Tunisia
Sanofi-Aventis Investigational Site Number 78803
🇹🇳Monastir, Tunisia
Sanofi-Aventis Investigational Site Number 78801
🇹🇳Tunis, Tunisia
Sanofi-Aventis Investigational Site Number 86201
🇻🇪Caracas, Venezuela
Sanofi-Aventis Investigational Site Number 42203
🇱🇧Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 07604
🇧🇷São José, Brazil
Sanofi-Aventis Investigational Site Number 42204
🇱🇧Beirut, Lebanon