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

Phase 4

Completed

• Conditions: Hypertension; Diabetes Mellitus Type 2

• Registration Number: NCT00549133
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-04
• Status Verified: 2007-10
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Last Update Submitted: 2007-10-24
• Study First Posted: 2007-10-25
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇷 Istanbul, Turkey