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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: IRBESARTAN
* Drug: Atenolol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan Group<br>150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks | Drug: IRBESARTAN<br>* Tablets<br>|
| Active Comparator: Atenolol Group<br>50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks. | Drug: Atenolol<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound. |  | at baseline and at the end of the study-12th wk |