APROVE : Irbesartan in Hypertension

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Irbesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00283036

L_8793

Details and patient eligibility

About

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

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)