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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: IRBESARTAN; Drug: Atenolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529750

L_8261

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Irbesartan Group

Experimental group

Description:

150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks

Treatment:

Drug: IRBESARTAN

Atenolol Group

Active Comparator group

Description:

50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.

Treatment:

Drug: Atenolol