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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan

• Registration Number: NCT00564187
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2004-12
• Status Verified: 2007-11
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Last Update Submitted: 2007-11-27
• Last Update Posted: 2007-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Irbesartan	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
2	Irbesartan	• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
• 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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇳 Megrine, Tunisia