Phase 2
N=76
A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01522950 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in Small Artery Elasticity — 2.4; 1.0; 0.4 (ml/mmHg × 100)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nebivolol (Drug); atenolol (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Small Artery Elasticity |
2.4; 1.0; 0.4 | — |
| SECONDARY Change in Large Artery Elasticity |
3.2; 2.9; 0.2 | — |
| SECONDARY Change in Systolic Blood Pressure |
-9; -13; -3.2 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-8.5; -8.5; -2.9 | — |
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.
Eligibility 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.
Data sourced from ClinicalTrials.gov (NCT01522950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.