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APROVE : Irbesartan in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283036
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : April 3, 2008
Bristol-Myers Squibb
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Brief Summary:
Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients
Study Start Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Primary Outcome Measures :
  1. Arterial Tension
  2. Tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283036

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Alger, Algeria
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Nabil BENOUNICHE, MD Sanofi
Layout table for additonal information Identifier: NCT00283036    
Other Study ID Numbers: L_8793
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action