Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol - Full Text View

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

This study has been completed.

First Received: October 24, 2007 No Changes Posted

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00549133

Purpose

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
Hypertension Diabetes Mellitus Type 2	Drug: Irbesartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Atenolol Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549133

Locations

Turkey
Sanofi-aventis
Istanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Edibe Taylan

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	L_9130
Study First Received:	October 24, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00549133 History of Changes
Health Authority:	Turkey: Ministry of Health

Keywords provided by Sanofi-Aventis:

Microalbuminaria in hypertensive patients with type II diabetes mellitus

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Vascular Diseases
Irbesartan
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010