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

NCT00529750 | Completed Phase 4

• 1 other identifier: L_8261
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Irbesartan Group

EXPERIMENTAL

150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks

Drug: IRBESARTAN

Atenolol Group

ACTIVE COMPARATOR

50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.

Drug: Atenolol

Interventions

IRBESARTAN DRUG

Tablets

Irbesartan Group

Atenolol DRUG

Tablets

Atenolol Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Juan Carlos Gomez

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: July 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: January 12, 2011

Record last verified: 2011-01