APROVE : Irbesartan in Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irbesartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg.
* Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet
* Patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion.
* Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total cholesterol) and ECG during the month prior to inclusion.

Exclusion Criteria

* Severe Hypertension defined by PAS \> 180mmHg and/or PAD \> 110 mmHg.
* Isolated systolic Hypertension
* Secondary Hypertension
* Arterial stenosis on unique kidney - arterial bilateral kidney stenosis
* Non-surgically sterilized women or non-menopaused women.
* Confirmed sodic depletion.
* Hypersensitivity to Irbesartan.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nabil BENOUNICHE, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Algiers, , Algeria

Site Status

Countries

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Algeria

Other Identifiers

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L_8793

Identifier Type: -

Identifier Source: org_study_id