This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

APROVE : Irbesartan in Hypertension

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
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

Condition Intervention Phase
Hypertension Drug: Irbesartan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Arterial Tension
  • Tolerability

Estimated Enrollment: 200
Study Start Date: April 2005

Ages Eligible for Study:   Child, Adult, Senior
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00283036

Alger, Algeria
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Nabil BENOUNICHE, MD Sanofi
  More Information Identifier: NCT00283036     History of Changes
Other Study ID Numbers: L_8793
Study First Received: January 26, 2006
Last Updated: April 1, 2008

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017