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Trial record 57 of 116 for:    Atenolol

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

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ClinicalTrials.gov Identifier: NCT00529750
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: IRBESARTAN Drug: Atenolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

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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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529750


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Juan Carlos Gomez Sanofi

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ClinicalTrials.gov Identifier: NCT00529750     History of Changes
Other Study ID Numbers: L_8261
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Atenolol
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia 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