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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Irbesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564187

L_8484

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Irbesartan

Drug: Irbesartan

2

Active Comparator group

Description:

• Or 300 mg/day for non responding patients and responding patients non normalized randomized in the group B

Treatment:

Drug: Irbesartan

Drug: Irbesartan