Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
NCT ID: NCT00956644
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
406 participants
INTERVENTIONAL
2009-07-31
2010-08-31
Brief Summary
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* 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
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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 : 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
irbesartan/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
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
amlodipine
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
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 in the morning
amlodipine
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
Eligibility Criteria
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Inclusion Criteria
* Treated with amlodipine 5 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 by 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 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
* Known type 1 diabetes
* Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal or history or hepatic encephalopathy, esophageal varices, or portocaval shunt
* Known 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 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 07602
Campinas, , Brazil
Sanofi-Aventis Investigational Site Number 076-005
Rio de Janeiro, , Brazil
Sanofi-Aventis Investigational Site Number 07605
Rio de Janeiro, , Brazil
Sanofi-Aventis Investigational Site Number 07604
São José, , Brazil
Sanofi-Aventis Investigational Site Number 07601
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 076-004
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 076-002
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 07603
São Paulo, , Brazil
Sanofi-Aventis Investigational Site Number 15202
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 15203
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 15204
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 15205
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 15206
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 17003
Barranquilla, , Colombia
Sanofi-Aventis Investigational Site Number 17004
Barranquilla, , Colombia
Sanofi-Aventis Investigational Site Number 17002
Medellín, , Colombia
Sanofi-Aventis Investigational Site Number 81803
Alexandria, , Egypt
Sanofi-Aventis Investigational Site Number 81804
Alexandria, , Egypt
Sanofi-Aventis Investigational Site Number 81801
Cairo, , Egypt
Sanofi-Aventis Investigational Site Number 81802
Cairo, , Egypt
Sanofi-Aventis Investigational Site Number 42202
Beirut, , Lebanon
Sanofi-Aventis Investigational Site Number 42203
Beirut, , Lebanon
Sanofi-Aventis Investigational Site Number 42204
Beirut, , Lebanon
Sanofi-Aventis Investigational Site Number 42205
Beirut, , Lebanon
Sanofi-Aventis Investigational Site Number 42206
Beirut, , Lebanon
Sanofi-Aventis Investigational Site Number 48401
Durango, , Mexico
Sanofi-Aventis Investigational Site Number 48402
Guadalajara, , Mexico
Sanofi-Aventis Investigational Site Number 48403
Guadalajara, , Mexico
Sanofi-Aventis Investigational Site Number 48406
Guadalajara, , Mexico
Sanofi-Aventis Investigational Site Number 48404
Guadalajara, , Mexico
Sanofi-Aventis Investigational Site Number 48405
México, , Mexico
Sanofi-Aventis Investigational Site Number 48407
México, , Mexico
Sanofi-Aventis Investigational Site Number 50401
Casablanca, , Morocco
Sanofi-Aventis Investigational Site Number 50402
Marrakesh, , Morocco
Sanofi-Aventis Investigational Site Number 50403
Marrakesh, , Morocco
Sanofi-Aventis Investigational Site Number 78804
Aryanah, , Tunisia
Sanofi-Aventis Investigational Site Number 78803
Monastir, , Tunisia
Sanofi-Aventis Investigational Site Number 78802
Sfax, , Tunisia
Sanofi-Aventis Investigational Site Number 78801
Tunis, , Tunisia
Sanofi-Aventis Investigational Site Number 86201
Caracas, , Venezuela
Countries
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References
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Bobrie G; I-COMBINE Study Investigators. I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1705-19. doi: 10.1016/j.clinthera.2012.06.026. Epub 2012 Jul 30.
Other Identifiers
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IRBAM_R_04220
Identifier Type: -
Identifier Source: org_study_id