Hypertension | A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Hypertension research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Nebivolol5 mg daily or 10 mg daily
Drug:atenolol25 mg daily or 50 mg daily
Drug:placeboone tablet daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Nebivolol5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Atenolol25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
PlaceboContinue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Start Date: May 2010
Completed Date: October 2016
Phase: Phase 2
Primary Outcome: Comparing effects of nebivolol against atenolol and placebo on endothelial function
Secondary Outcome: Evaluate effects of nebivolol as compared to atenolol and placebo
Study sponsors, principal investigator, and references
Principal Investigator: Jay N Cohn, MD
Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute
Collaborator: Forest Laboratories