Status:
COMPLETED
A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled study comparing the efficacy of nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular disease risk in subjects ...
Detailed Description
The Rasmussen Disease Score (RDS) test panel is the chosen methodology for this study. The 10 parameters of the RDS were selected because of their ability to quantify early structural and functional a...
Eligibility Criteria
Inclusion
- borderline blood pressure (120-145/80-90 mm Hg);
- borderline or abnormal small artery elasticity (C2) as measured by pulse contour analysis;
- treatment-naive for all blood pressure medications including diuretics for at least 30 days prior to baseline visit;
- able to walk on a treadmill for 3 minutes;
- female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device during and for 1 month after the last dose of study drug;
- voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion
- history of intolerance to beta-blockers or clear contraindications to their use; current pharmaceutical treatment of blood pressure;
- known history of cardiovascular disease (myocardial infarction, coronary artery bypass graft, unstable angina, uncontrolled arrhythmias, stroke, etc.);
- known history of diabetes; known history of hepatic, renal or gastrointestinal disorder;
- known history of any illness that may cause additional risk (as determined by study investigator);
- pregnant or lactating women \[when used during pregnancy, beta-blockers may cause fetal harm\];
- participation in a concomitant clinical trial.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01522950
Start Date
May 1 2010
End Date
October 1 2016
Last Update
July 17 2020
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455