Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
- Registration Number
- NCT00957554
- Lead Sponsor
- Sanofi
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 435
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description irbesartan/amlodipine irbesartan/amlodipine Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 300/5 mg fixed combination for additional 5 weeks irbesartan irbesartan Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks
- Primary Outcome Measures
Name Time Method Mean home systolic blood pressure At randomisation and week 10
- 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 (38)
Sanofi-Aventis Investigational Site Number 48401
🇲🇽Mérida, Mexico
Sanofi-Aventis Investigational Site Number 48407
🇲🇽San Luis Potosi, Mexico
Sanofi-Aventis Investigational Site Number 17003
🇨🇴Cartagena, Colombia
Sanofi-Aventis Investigational Site Number 32001
🇬🇹Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 78803
🇹🇳Tunis, Tunisia
Sanofi-Aventis Investigational Site Number 07601
🇧🇷Sorocaba, Brazil
Sanofi-Aventis Investigational Site Number 07605
🇧🇷Belo Horizonte, Brazil
Sanofi-Aventis Investigational Site Number 17001
🇨🇴Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 07604
🇧🇷Maceió, Brazil
Sanofi-Aventis Investigational Site Number 07602
🇧🇷Caxias do Sul, Brazil
Sanofi-Aventis Investigational Site Number 17002
🇨🇴Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 07603
🇧🇷São José do Rio Preto, Brazil
Sanofi-Aventis Investigational Site Number 32003
🇬🇹Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 32002
🇬🇹Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 32004
🇬🇹Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 50401
🇲🇦Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50406
🇲🇦Rabat, Morocco
Sanofi-Aventis Investigational Site Number 48403
🇲🇽San Luis Potosi, Mexico
Sanofi-Aventis Investigational Site Number 48408
🇲🇽Zapopan, Mexico
Sanofi-Aventis Investigational Site Number 32005
🇬🇹Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 48402
🇲🇽Guadalajara, Mexico
Sanofi-Aventis Investigational Site Number 48406
🇲🇽Mexico, Mexico
Sanofi-Aventis Investigational Site Number 48404
🇲🇽Torreon, Mexico
Sanofi-Aventis Investigational Site Number 50403
🇲🇦Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50402
🇲🇦Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50405
🇲🇦Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50404
🇲🇦Rabat, Morocco
Sanofi-Aventis Investigational Site Number 78805
🇹🇳Ariana, Tunisia
Sanofi-Aventis Investigational Site Number 78804
🇹🇳La marsa, Tunisia
Sanofi-Aventis Investigational Site Number 78802
🇹🇳Menzel Bourguiba, Tunisia
Sanofi-Aventis Investigational Site Number 78813
🇹🇳Monastir, Tunisia
Sanofi-Aventis Investigational Site Number 78815
🇹🇳Sousse, Tunisia
Sanofi-Aventis Investigational Site Number 78812
🇹🇳Tunis, Tunisia
Sanofi-Aventis Investigational Site Number 78801
🇹🇳Tunis, Tunisia
Sanofi-Aventis Investigational Site Number 78807
🇹🇳Tunis, Tunisia
Sanofi-Aventis Investigational Site Number 784-02
🇦🇪Dubai, United Arab Emirates
Sanofi-Aventis Investigational Site Number 784-001
🇦🇪Abu Dhabi, United Arab Emirates
Sanofi-Aventis Investigational Site Number 86201
🇻🇪Maracaibo, Venezuela