Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension

Primary:

* To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.

Secondary:

* To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome. * To correlate the oxidative stress status with endothelial function in these patients. * To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function . * To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hypertension grade 1 or 2
With at least two of the following criteria for the diagnosis of metabolic syndrome:

Body mass index > or = 25 kg/m2 AND waist circumference > or = 100 cm.
Dyslipidemia (triglycerides fasting serum levels > or = 200 mg/dL OR HDL serum levels < or = 40 mg/dL)
Fasting serum glucose > or = 110 mg/dL but < 126 mg/dL

Exclusion criteria

Known hypersensitivity to Irbesartan
Hypertension grade 3
History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
Coronary artery disease
Renal insufficiency (creatinine serum levels > or = 1.2 mg/dL)
Presence of clinical heart failure
Asthma and COPD
Valvular cardiopathy clinically relevant
Current therapy with antioxidant drugs, statins
Therapy with AIIRA for at least 3 months during the last semester
Presence of any acute illness or major trauma in the last 8 weeks
History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.

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

Tablets

Atenolol

Drug

Tablets

Primary outcomes

Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.

Time frame: at baseline and at the end of the study-12th wk

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Sep 14, 2007
Registry last updated: Jan 12, 2011

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