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
- To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Experimental: Irbesartan Group
150 mg p.o. once a day, 30 minutes before breakfast during 12 weeks
Active Comparator: Atenolol Group
50 mg p.o. once a day, 30 minutes before breakfast during 12 weeks.
- 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 ]
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
|Study Director:||Juan Carlos Gomez||Sanofi|