A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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 with early vascular disease. Approximately 75 subjects with borderline/elevated blood pressures and impaired endothelial function, as measured by arterial elasticity scores, will be recruited and assigned to treatment groups using a block randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo, and then followed for 9 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Forest Laboratories
• Treatments: Atenolol; Nebivolol

Criteria

Inclusion Criteria:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 Criteria:

• 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.