Official Title: “Irbesartan in Mild to Moderate Hypertensive Patients”

- To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients. - To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc…) at the end of the trial.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

• Drug: Irbesartan (Aprovel)
  • Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.

Primary Measures

• Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.
  • Time Frame: During the study conduct
    Safety Issue?: No

Secondary Measures

• Occurrence of any side effects leading to treatment discontinuation.
  • Time Frame: During the study conduct
    Safety Issue?: Yes

Inclusion Criteria:

• Patients with proved mild to moderate hypertension.
• Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
• Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

• Severe hypertension (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
• Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
• Patients with HbA1c > 10%.
• Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
• Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 2.5 times the upper limit of the normal range.
• Currently pregnant or lactating females.
• Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
• Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his physician).
• Known hypersensitivity to irbesartan, other ARBs (Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
• Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Mosaad I Morsi, MBBCh, MSc Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00335673

Study ID Number: IRBES_L_00165

ClinicalTrials.gov Identifier: NCT00335673

Health Authority: Egypt: Ministry of Health and Population