search
Back to results

Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol (IREDIS)

Primary Purpose

Hypertension, Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Irbesartan
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Microalbuminaria in hypertensive patients with type II diabetes mellitus

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
  • mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion Criteria:

  • congestive heart failure
  • azotemia
  • insulin dependent diabetes
  • liver insufficiency
  • pregnancy
  • cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)

Secondary Outcome Measures

Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.

Full Information

First Posted
October 24, 2007
Last Updated
October 24, 2007
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00549133
Brief Title
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Acronym
IREDIS
Official Title
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus Type 2
Keywords
Microalbuminaria in hypertensive patients with type II diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Irbesartan
Primary Outcome Measure Information:
Title
Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol)
Secondary Outcome Measure Information:
Title
Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8 mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg) Exclusion Criteria: congestive heart failure azotemia insulin dependent diabetes liver insufficiency pregnancy cancer The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

We'll reach out to this number within 24 hrs