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

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Acronym: IREDIS

Important dates

Study start: 2003
Study completion: 2005
First posted: Oct 25, 2007
Registry last updated: Oct 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed