Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
NCT ID: NCT00957554
Last Updated: 2010-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
435 participants
INTERVENTIONAL
2009-07-31
2010-09-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily
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
irbesartan
Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily
Interventions
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irbesartan/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily
irbesartan
Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily
Eligibility Criteria
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Inclusion Criteria
* Treated with irbesartan 150 mg monotherapy for at least 4 weeks
* With uncontrolled BP defined as mean SBP = or \> 145 mmHg assessed by OBPM
* Signed written inform consent obtained prior to inclusion in the study
Randomisation Criteria:
* Mean SBP = or \> 135 mmHg assessed by HBPM
* Good compliance with the HBPM protocol defined as at least 12 correct measurements performed over the last 6 days of the first period of measurements
* Creatinine clearance = or \> 30 ml/min determined ny Cockroft formula
Exclusion Criteria
* Known or suspected causes of secondary hypertension
* Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only has one functioning kidney
* Know contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Know type 1 diabetes
* Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt
* Know severe renal impairment (creatinine clearance \< 30 ml/mn)
* Concomitant use of any other antihypertensive treatment
* Administration of any other investigational drug within 30 days before inclusion
* Inability to obtain a valid automatic BP measurement recording
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of of the patient
* Presence of any other conditions (e.g.: geographical, social, etc) that would restrict or limit the patient participation for the duration of the study
* Pregnant or breast feeding women
* Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Nathalie Genes, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Investigational Site Number 07605
Belo Horizonte, , Brazil
Sanofi-Aventis Investigational Site Number 07602
Caxias do Sul, , Brazil
Sanofi-Aventis Investigational Site Number 07604
Maceió, , Brazil
Sanofi-Aventis Investigational Site Number 07603
São José do Rio Preto, , Brazil
Sanofi-Aventis Investigational Site Number 07601
Sorocaba, , Brazil
Sanofi-Aventis Investigational Site Number 17001
Barranquilla, , Colombia
Sanofi-Aventis Investigational Site Number 17002
Barranquilla, , Colombia
Sanofi-Aventis Investigational Site Number 17003
Cartagena, , Colombia
Sanofi-Aventis Investigational Site Number 32001
Guatemala City, , Guatemala
Sanofi-Aventis Investigational Site Number 32002
Guatemala City, , Guatemala
Sanofi-Aventis Investigational Site Number 32003
Guatemala City, , Guatemala
Sanofi-Aventis Investigational Site Number 32004
Guatemala City, , Guatemala
Sanofi-Aventis Investigational Site Number 32005
Guatemala City, , Guatemala
Sanofi-Aventis Investigational Site Number 48402
Guadalajara, , Mexico
Sanofi-Aventis Investigational Site Number 48401
Mérida, , Mexico
Sanofi-Aventis Investigational Site Number 48406
México, , Mexico
Sanofi-Aventis Investigational Site Number 48403
San Luis Potosí City, , Mexico
Sanofi-Aventis Investigational Site Number 48407
San Luis Potosí City, , Mexico
Sanofi-Aventis Investigational Site Number 48404
Torreón, , Mexico
Sanofi-Aventis Investigational Site Number 48408
Zapopan, , Mexico
Sanofi-Aventis Investigational Site Number 50403
Casablanca, , Morocco
Sanofi-Aventis Investigational Site Number 50401
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 50406
Rabat, , Morocco
Sanofi-Aventis Investigational Site Number 78805
Aryanah, , 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 78801
Tunis, , Tunisia
Sanofi-Aventis Investigational Site Number 78812
Tunis, , Tunisia
Sanofi-Aventis Investigational Site Number 78803
Tunis, , Tunisia
Sanofi-Aventis Investigational Site Number 78807
Tunis, , Tunisia
Sanofi-Aventis Investigational Site Number 784-001
Abu Dhabi, , United Arab Emirates
Sanofi-Aventis Investigational Site Number 784-02
Dubai, , United Arab Emirates
Sanofi-Aventis Investigational Site Number 86201
Maracaibo, , Venezuela
Countries
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References
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Bobrie G; I-ADD Study Investigators. I-ADD study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with irbesartan monotherapy in hypertensive patients uncontrolled with irbesartan 150 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1720-34.e3. doi: 10.1016/j.clinthera.2012.07.001. Epub 2012 Jul 30.
Other Identifiers
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IRBAM_R_04219
Identifier Type: -
Identifier Source: org_study_id