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

January 11, 2011 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at baseline and at the end of the study-12th wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (ESTIMATE)

September 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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