Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
NCT ID: NCT00529750
Last Updated: 2011-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2002-07-31
2005-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Irbesartan Group
150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks
IRBESARTAN
Tablets
Atenolol Group
50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.
Atenolol
Tablets
Interventions
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IRBESARTAN
Tablets
Atenolol
Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Juan Carlos Gomez
Role: STUDY_DIRECTOR
Sanofi
Other Identifiers
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L_8261
Identifier Type: -
Identifier Source: org_study_id
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