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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Diabetes Mellitus Type 2

Intervention: Irbesartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Edibe Taylan, Study Director, Affiliation: Sanofi

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Istanbul, Turkey
Additional Information

Starting date: October 2003
Last updated: October 24, 2007

Page last updated: August 23, 2015

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