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

Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529750

Enrollment

108

Registered

2007-09-14

Start date

2002-07-31

Completion date

2005-01-31

Last updated

2011-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGIRBESARTAN

Tablets

DRUGAtenolol

Tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026