APROVE : Irbesartan in Hypertension

Hypertension Clinical Trial

Official title:

Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283036
• Other study ID #: L_8793
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2006
• Last updated: April 1, 2008
• Start date: April 2005

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Algeria: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Irbesartan

Locations

Country	Name	City	State
Algeria	Sanofi-Aventis	Alger

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Tension
Primary	Tolerability