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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549133
First Posted: October 25, 2007
Last Update Posted: October 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
October 24, 2007
October 25, 2007
October 25, 2007
October 2003
Not Provided
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)
Same as current
No Changes Posted
Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol.
Same as current
Not Provided
Not Provided
 
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Diabetes Mellitus Type 2
Drug: Irbesartan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2005
Not Provided

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.

Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT00549133
L_9130
No
Not Provided
Not Provided
Not Provided
Sanofi
Not Provided
Study Director: Edibe Taylan Sanofi
Sanofi
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP