Clinical trial NCT00957554: Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Official title: Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Established essential hypertension
* 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:

* Mean SBP = or \> 180 mmHg and/or mean DBP = or \> 110 mmHg measured at doctor's office at Visit 1
* 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.

Primary outcomes:
measure: Mean home systolic blood pressure
timeFrame: At randomisation and week 10
Secondary outcomes:
measure: Mean office blood pressure
timeFrame: At randomisation, week 5 and week 10
measure: Mean home diastolic blood pressure
timeFrame: At randomisation, week 5 and week 10
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 07605
city: Caxias do Sul
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 07602
city: Maceió
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 07604
city: Sorocaba
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 07601
city: São José do Rio Preto
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 07603
city: Barranquilla
country: Colombia
facility: Sanofi-Aventis Investigational Site Number 17001
city: Barranquilla
country: Colombia
facility: Sanofi-Aventis Investigational Site Number 17002
city: Cartagena
country: Colombia
facility: Sanofi-Aventis Investigational Site Number 17003
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis Investigational Site Number 32001
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis Investigational Site Number 32002
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis Investigational Site Number 32003
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis Investigational Site Number 32004
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis Investigational Site Number 32005
city: Guadalajara
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48402
city: Mexico
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48406
city: Mérida
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48401
city: San Luis Potosi
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48403
city: San Luis Potosi
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48407
city: Torreon
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48404
city: Zapopan
country: Mexico
facility: Sanofi-Aventis Investigational Site Number 48408
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50403
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50401
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50402
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50405
city: Rabat
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50404
city: Rabat
country: Morocco
facility: Sanofi-Aventis Investigational Site Number 50406
city: Ariana
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78805
city: La marsa
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78804
city: Menzel Bourguiba
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78802
city: Monastir
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78813
city: Sousse
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78815
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78801
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78812
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78803
city: Tunis
country: Tunisia
facility: Sanofi-Aventis Investigational Site Number 78807
city: Abu Dhabi
country: United Arab Emirates
facility: Sanofi-Aventis Investigational Site Number 784-001
city: Dubai
country: United Arab Emirates
facility: Sanofi-Aventis Investigational Site Number 784-02
city: Maracaibo
country: Venezuela
facility: Sanofi-Aventis Investigational Site Number 86201
Study officials:
affiliation: Sanofi
name: Nathalie Genes, MD
role: STUDY_DIRECTOR
References:
citation: 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.