Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Study Overview
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Brief Summary
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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

Official Title
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Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: irbesartan/amlodipine
* Drug: irbesartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irbesartan/amlodipine<br>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 | Drug: irbesartan/amlodipine<br>* Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily<br>|
| Active Comparator: irbesartan<br>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 | Drug: irbesartan<br>* Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean home systolic blood pressure |  | At randomisation and week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean office blood pressure |  | At randomisation, week 5 and week 10 | 
| Mean home diastolic blood pressure |  | At randomisation, week 5 and week 10 |