Coreg CR, Blood Vessel Stiffness and Blood Vessel Function
Recruitment status was: Recruiting
|Endothelial Function Diabetes Mellitus Hypertension||Drug: carvedilol Drug: metoprolol extended release||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||Effect of Coreg CR on BP, Endothelial Function, Exhaled Nitric Oxide, and Nitric Oxide Production and Oxidation|
- Effect of Coreg CR compared to Toprol XL on endothelial function, vascular compliance, and parameters of oxidative stress from time of randomization to study drug termination [ Time Frame: 12 weeks ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||April 2009|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Coreg Cr will be up-titrated as needed to achieve blood pressure <130/80
capsules in doses of 20, 40, and 80 mg; once daily; 12 weeks duration
Other Name: Coreg CR
Active Comparator: 2
Toprol XL will be up-titrated at weekly intervals to achieve a blood pressure <130/80 mm Hg
Drug: metoprolol extended release
tablets in doses 50, 100, and 200 mg; once daily; 12 weeks duration
Other Name: Toprol XL
The following techniques will be used:
Endothelial function will be measured non-invasively by flow-mediated changes in pulsatile blood volume in the finger-tips.
Vascular compliance (stiffness) will be assessed by tonometry of the radial pulse wave ("augmentation index") and diastolic puse wave analysis.
Plasma nitrate/nitrite levels mirror NO production and will be measured spectrophotometrically by the Griess reaction.
Plasma nitrotyrosine, an in vivo marker of NO-dependent damage induced by reactive nitrogen intermediates derived from NO, will be measured by ELISA.
Exhaled NO may provide an real-time measure of endothelial cell NO production and can be measured by a hand-held device which contains an electrochemical detector sensitive to 5 ppb.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732511
|Contact: Nathaniel Winer, M.D.||email@example.com|
|Contact: Rozina Rana, M.D.||firstname.lastname@example.org|
|United States, New York|
|SUNY Downstate Medical Center||Recruiting|
|Brooklyn, New York, United States, 11203|
|Contact: Nathaniel Winer, M.D. 718-270-6320 email@example.com|
|Contact: Rozina Rana, M.D. 516-279-8092 firstname.lastname@example.org|
|Principal Investigator:||Nathaniel Winer, M.D.||Stae University of New York Downstate Medical Center|