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

Sanofi115 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Hypertension

Interventions

IrbesartanDRUG

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

IrbesartanDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Mégrine, Tunisia

Outcomes

Primary Outcomes

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)

Time frame: at 6 weeks of treatment

Secondary Outcomes

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

Time frame: at 6 and 12 weeks

• To evaluate rate of adverse events

Time frame: during the study duration

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

Time frame: at 6 and 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.