Status:
COMPLETED
APROVE : Irbesartan in Hypertension
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypertension
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00283036
Start Date
April 1 2005
Last Update
April 3 2008
Active Locations (1)
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1
Sanofi-Aventis
Algiers, Algeria