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

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

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

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.