Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: IRBESARTAN (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Juan Carlos Gomez, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
Official title: Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
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.
Locations and Contacts
Additional Information
clinicalstudyresults.org
Starting date: July 2002
Last updated: March 3, 2008
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