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Trial record 58 of 117 for:    Atenolol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00529750
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE September 12, 2007
First Posted Date  ICMJE September 14, 2007
Last Update Posted Date January 12, 2011
Study Start Date  ICMJE July 2002
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
Official Title  ICMJE Comparative Trial of the Effects of Irbesartan vs Atenolol on the Endothelial Function of Hypertensive Patients With Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: IRBESARTAN
    Tablets
  • Drug: Atenolol
    Tablets
Study Arms  ICMJE
  • Experimental: Irbesartan Group
    150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks
    Intervention: Drug: IRBESARTAN
  • Active Comparator: Atenolol Group
    50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.
    Intervention: Drug: Atenolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2007)
108
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00529750
Other Study ID Numbers  ICMJE L_8261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Juan Carlos Gomez Sanofi
PRS Account Sanofi
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP