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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00529750

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: IRBESARTAN Drug: Atenolol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Metabolic Syndrome

Drug Information available for: Angiotensin II Atenolol Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Endothelial function in vivo qualification: brachial artery flow mediated vasodilation (FMV%) determined by high resolution ultrasound. [ Time Frame: at baseline and at the end of the study-12th wk ]

Enrollment:	108
Study Start Date:	July 2002
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Irbesartan Group 150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks	Drug: IRBESARTAN Tablets
Active Comparator: Atenolol Group 50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.	Drug: Atenolol Tablets

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529750

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Juan Carlos Gomez

Sanofi-Aventis

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00529750 History of Changes
Other Study ID Numbers:	L_8261
Study First Received:	September 12, 2007
Last Updated:	January 11, 2011
Health Authority:	Columbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Irbesartan
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on February 09, 2012