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...
Date First Received: October 24, 2007
Last Updated: October 24, 2007
Verified by: Sanofi-Aventis, October 2007
Clinical Trial Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 44
Brief Summary
Official Title: “Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Irbesartan
Outcome Measures for this Clinical Trial
Primary 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 Measures
- Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Edibe Taylan Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00549133
Study ID Number: L_9130
ClinicalTrials.gov Identifier: NCT00549133
Health Authority: Turkey: Ministry of Health
Clinical Trials Authorship and Review
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