APROVE : Irbesartan in Hypertension
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive...
Brief Summary
Official Title: “Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients”
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Irbesartan
Outcome Measures for this Clinical Trial
Primary Measures
- Arterial Tension
- Tolerability
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Nabil BENOUNICHE, MD Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00283036
Study ID Number: L_8793
ClinicalTrials.gov Identifier: NCT00283036
Health Authority: Algeria: Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00283036
