Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
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-Aventis Official(s) and/or principal investigator(s):
Edibe Taylan, Study Director, Affiliation: Sanofi-Aventis
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: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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
clinicalstudyresults.org
Starting date: October 2003
Ending date: April 2005
Last updated: October 24, 2007
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