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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

• Mild to Moderate hypertension (90mmHg- 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.