Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Study Overview
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Brief Summary
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Primary: To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks) Secondary: To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks To evaluate rate of adverse events during the study

Official Title
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Prospective, Multicentric, Randomized, Open, Comparative Phase IV Study Evaluating the Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan
* Drug: Irbesartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to Moderate hypertension (90mmHg<DBP<110mmHg and 140mmHg<SBP<180mmHg) Or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet Or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion A minimum exam labs as required by WHO-ISH within the month before the inclusion Exclusion Criteria: Severe Arterial Hypertension (PAS > than or = to 180 mm Hg or PAD > than or = to 110 mmHg) Isolated Systolic Hypertension Secondary Hypertension Bilateral renal arterial stenosis or renal arterial stenosis Non surgically sterilised woman or non post-menopausal woman Confirmed sodium depletion Irbesartan hypersensitivity 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: 1<br>Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • 150mg/day for normalized patients and patients responding non normalized randomized in the group A | Drug: Irbesartan<br>* Irbesartan: 150mg tablets Dosage: Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • 150mg/day for normalized patients and patients responding non normalized randomized in the group A<br>|
| Active Comparator: 2<br>• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B | Drug: Irbesartan<br>* Irbesartan: 150mg tablets Until 6 weeks: 150mg/day, then a dosage adjustment according to the blood pressure(normalized: DBP<90mmHg, responding non normalized:DBP≥90mmHg and a decrease of DBP≥10mmHg, non responding: decrease of DBP<10mmHg and DBP≥90mmHg) for the period between 6 and 12 weeks: • Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized (schema N°1: maintenance 150mg/day, schema n°2: 300mg/day for 6 more weeks) |  | at 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To evaluate the percentage of patients with DBP<90 mmHg |  | at 6 and 12 weeks | 
| • To evaluate rate of adverse events |  | during the study duration | 
| • To evaluate the percentage of patients with SBP<140 mmHg |  | at 6 and 12 weeks |