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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Angiotensin Receptor Antagonists; Atenolol; Irbesartan

Criteria

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.