Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
- Registration Number
- NCT00529750
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 108
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Irbesartan Group IRBESARTAN 150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks Atenolol Group Atenolol 50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method