Official Title: “Irbesartan In Hypertensive Diabetic Patients”

- To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients. - To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population. - To demonstrate the safety of Irbesartan in this population.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

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

Primary Measures

• Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
  • Time Frame: During the study conduct
    Safety Issue?: No

Secondary Measures

• The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)
  • Time Frame: During the study conduct
    Safety Issue?: No
• First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions)
  • Time Frame: During the study conduct
    Safety Issue?: No
• Occurrence of any side effect leading to treatment discontinuation.
  • Time Frame: During the study conduct
    Safety Issue?: Yes

Inclusion Criteria:

• Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or without microalbuminuria).
• Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension).
• OR,
• Patients who were receiving antihypertensive agents (maximum two agents, including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients 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 (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
• Patients with secondary hypertension.
• Patients with UAE > 200µg / min.
• Patients with HbA1c < 6% or > 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/her 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: 35 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 October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362258

Study ID Number: PM_L_0256

ClinicalTrials.gov Identifier: NCT00362258

Health Authority: Egypt: Ministry of Health and Population