I PREVENT - Irbesartan In Hypertensive Diabetic Patients

NCT ID: NCT00362258

Last Updated: 2011-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 797 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-09-30

Brief Summary

• 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.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Irbesartan (Aprovel)

Aprovel (150 \& 300mg) \& CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Mosaad I Morsi, MBBCh, MSc

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PM_L_0256

Identifier Type: -

Identifier Source: org_study_id