I PREVENT - Irbesartan In Hypertensive Diabetic Patients

April 1, 2011 updated by: Sanofi

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

797

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)
Time Frame: During the study conduct
During the study conduct
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
During the study conduct
Occurrence of any side effect leading to treatment discontinuation.
Time Frame: During the study conduct
During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 9, 2006

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM_L_0256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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