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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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

Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Irbesartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Enrollment: 44
Study Start Date: October 2003
Study Completion Date: April 2005

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00549133

Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan Sanofi
  More Information Identifier: NCT00549133     History of Changes
Other Study ID Numbers: L_9130 
Study First Received: October 24, 2007
Last Updated: October 24, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by Sanofi:
Microalbuminaria in hypertensive patients with type II diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016