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

Condition(s) targeted: Hypertension

Intervention: Irbesartan (Drug); Irbesartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Chokri Jeribi, Study Director, Affiliation: Sanofi-Aventis

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: 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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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)

Secondary outcome:

• To evaluate the percentage of patients with DBP<90 mmHg

• To evaluate rate of adverse events

• To evaluate the percentage of patients with SBP<140 mmHg

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sanofi-Aventis, Megrine, Tunisia

clinicalstudyresults.org

Starting date: February 2003
Ending date: December 2004
Last updated: November 27, 2007