APROVE : Irbesartan in Hypertension
This study has been completed.
Information provided by:
First received: January 26, 2006
Last updated: April 1, 2008
Last verified: April 2008
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients
Primary Outcome Measures:
- Arterial Tension
| Estimated Enrollment:
| Study Start Date:
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283036
|Alger, Algeria |
||Nabil BENOUNICHE, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 26, 2006
||April 1, 2008
||Algeria: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 22, 2014
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action