Status:
COMPLETED
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Established essential hypertension
- 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:
- Mean SBP = or \> 180 mm Hg and/or mean DBP = or \> 110 mm Hg 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 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00956644
Start Date
July 1 2009
End Date
August 1 2010
Last Update
October 26 2010
Active Locations (40)
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1
Sanofi-Aventis Investigational Site Number 07602
Campinas, Brazil, 13059-900
2
Sanofi-Aventis Investigational Site Number 076-005
Rio de Janeiro, Brazil, 20551-030
3
Sanofi-Aventis Investigational Site Number 07605
Rio de Janeiro, Brazil, 20551-030
4
Sanofi-Aventis Investigational Site Number 07604
São José, Brazil, 88103-460