A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Completed · Phase 2 · Has a placebo group
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT01522950
- Run by
- University of Minnesota
- People needed
- 76
- Starts
- 2010-05-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2020-07-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
You may not qualify if…
- 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.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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