- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283036
APROVE : Irbesartan in Hypertension
April 1, 2008 updated by: Sanofi
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 Overview
Study Type
Interventional
Enrollment
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alger, Algeria
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Tolerability
|
Arterial Tension
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nabil BENOUNICHE, MD, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Registration Dates
First Submitted
January 26, 2006
First Submitted That Met QC Criteria
January 26, 2006
First Posted (Estimate)
January 27, 2006
Study Record Updates
Last Update Posted (Estimate)
April 3, 2008
Last Update Submitted That Met QC Criteria
April 1, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L_8793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on Irbesartan
-
The Affiliated Hospital of Qingdao UniversityCompleted
-
SanofiCompleted
-
SanofiBristol-Myers SquibbCompletedHypertensionUnited States
-
Steno Diabetes Center CopenhagenCompletedType 2 Diabetes | MicroalbuminuriaDenmark
-
Steno Diabetes Center CopenhagenBristol-Myers Squibb; Sanofi-SynthelaboCompletedHypertension | Type 2 Diabetes | Microalbuminuria
-
Bristol-Myers SquibbSanofiCompletedHypertensionUnited States, Belgium, Canada, Germany, Russian Federation, France, Israel, Netherlands
-
Travere Therapeutics, Inc.Active, not recruitingImmunoglobulin A NephropathyUnited States, Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Hong Kong, Italy, Korea, Republic of, Lithuania, New Zealand, Poland, Portugal, Spain, Taiwan, United Kingdom
-
University of Southern DenmarkBristol-Myers SquibbCompleted
-
SanofiBristol-Myers SquibbCompleted
-
SanofiBristol-Myers SquibbCompleted