CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 37 enrolled
Drug / intervention
Metoprolol +1 moredrug
Likely dose
Metoprolol 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00999102
NCT00999102Phase 4Completed

Nebivolol Vs. Metoprolol: Comparative Effects on Fatigue and Quality of Life

Weill Medical College of Cornell University·interventional·Posted Oct 21, 2009·Updated Oct 19, 2018

In Brief

A Phase 4 clinical trial evaluating Metoprolol and Nebivolol for Hypertension. Completed, enrolled 37 participants across 1 site.

Detailed Summary

Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living. A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of hypertension, appears to be far less associated with fatigue than are most currently available beta-blockers. The purpose of this study is to compare nebivolol with the current best-selling beta-blocker, metoprolol, and determine whether there is a significant difference in side effects including fatigue, reduced exertion tolerance, and reduced quality of life. In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4 weeks at a lower dose, and 4 weeks at a higher dose. All dosages are FDA-approved for treatment of hypertension. Subjects and investigators will not know which drug is being administered until completion of the study. Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If nebivolol is found to cause significantly less fatigue, it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy, and are living with reduced energy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2009
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.7 years ago

Interventions

Metoprololdrug

Metoprolol 50 mg, Metoprolol 100 mg,

Nebivololdrug

Nebivolol 5 mg, Nebivolol 10 mg.