ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

Study Overview
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Brief Summary
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To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

Official Title
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Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan - Hydrochlorothiazide
* Drug: Irbesartan - Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone With uncontrolled Blood Pressure (BP) defined as: SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients Exclusion Criteria: SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1 Known or suspected causes of secondary hypertension Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc…). Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used Known contraindications to the study drugs: Severe renal dysfunction (creatinine clearance <30ml/min) Known hypokaliemia (< 3 mmol/L) , known hypercalcemia Severe hepatic impairment, biliary cirrhosis, cholestasis Inability to obtain a valid automatic BP measurement recording Administration of any other investigational drug within 30 days prior to study entry and during the course of the study 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 subject. Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study. Pregnant or breast-feeding women Women of childbearing potential not protected by effective contraceptive method of birth control 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 |
| --- | --- |
| Active Comparator: Group 1<br>Usual elective titration regimen | Drug: Irbesartan - Hydrochlorothiazide<br>* 150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks<br>|
| Active Comparator: Group 2<br>Active elective titration regimen | Drug: Irbesartan - Hydrochlorothiazide<br>* 150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Systolic Blood Pressure |  | between Visit 1 (Week 0) and Visit 4 (Week 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Diastolic Blood Pressure |  | between Visit 1 (Week 0) and Visit 4 (Week 10) |