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APROVE : Irbesartan in Hypertension

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00283036
First received: January 26, 2006
Last updated: April 1, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Irbesartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients

Resource links provided by NLM:

Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Arterial Tension
  • Tolerability

Estimated Enrollment: 200
Study Start Date: April 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283036

Locations
Algeria
Sanofi-Aventis
Alger, Algeria
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Nabil BENOUNICHE, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283036     History of Changes
Other Study ID Numbers: L_8793
Study First Received: January 26, 2006
Last Updated: April 1, 2008
Health Authority: Algeria: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013