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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: IRBESARTAN

Primary Measures

• 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
    

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Juan Carlos Gomez Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00529750

Study ID Number: L_8261

ClinicalTrials.gov Identifier: NCT00529750

Health Authority: Columbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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