Overview

Nebivolol Versus Metoprolol: Sodium Sensitivity

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Research objectives The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to determine the effects of nebivolol versus metoprolol on ambulatory blood pressure, the blood pressure response to dietary sodium loading, and renal handling of an acute sodium load in postmenopausal women with hypertension. Hypothesis Nebivolol will result in a blunted response of blood pressure to oral sodium administration and improved renal handling of an intravenous sodium load in comparison with metoprolol in hypertensive postmenopausal women. Research plan Study design The study consisted of a randomized crossover trial of the effects on sodium sensitivity and renal sodium handling of nebivolol versus metoprolol. All study procedures were carried out under the direct supervision of the Principal Investigator in the outpatient and inpatient research unit of the University of Miami Division of Clinical Pharmacology. Primary endpoint Change in 24-hour mean systolic blood pressure determined by 24-hour ambulatory blood pressure monitor (ABPM) from the final day of low sodium to the final day of high sodium in nebivolol versus metoprolol
Phase:
Phase 4
Details
Lead Sponsor:
University of Miami
Collaborator:
Forest Laboratories
Treatments:
Metoprolol
Nebivolol