CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 96 enrolled
Drug / intervention
Nebivolol +1 moredrug
Likely dose
Nebivolol 5 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/NCT01041287
NCT01041287Phase 4Completed

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells in Subjects With Hypertension

Emory University·interventional·Posted Dec 31, 2009·Updated Dec 19, 2014

In Brief

A Phase 4 clinical trial evaluating Nebivolol and Metoprolol succinate for Hypertension. Completed, enrolled 96 participants across 1 site.

Detailed Summary

Hypertension, or high blood pressure, is a common disease that affects many Americans, and can lead to devastating consequences such as heart attack, stroke, and death if not treated. Nebivolol is a medication that has been recently approved by the FDA for the treatment of hypertension. Nebivolol has an unusual profile compared to other medications, in that its effects may be related to release of a substance called nitric oxide. Nitric oxide is released from the cells lining the blood vessels, and nebivolol may stimulate these cells to release more nitric oxide. Our study will investigate whether treatment with nebivolol, as compared to another medication called metoprolol, in hypertensive subjects will be more effective in protecting blood vessels against the harmful effects of high blood pressure. The mechanisms we will investigate include oxidative stress markers and circulating levels of endothelial progenitor cells.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2009
Enrollment StartDec 1, 2009
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.5 years ago

Interventions

Nebivololdrug

Nebivolol 5 mg PO qday for 2 weeks, titrated up to Nebivolol 10 mg PO qday if BP is \>125/80 for the 2 more weeks, and then titrated up to Nebivolol 20 mg PO qday if BP is \>125/80 for the remaining 8 weeks

Metoprolol succinatedrug

Metoprolol 50 mg PO qday for 2 weeks, titrated up to Metoprolol 100 mg PO qday if BP is \>125/80 for the 2 more weeks, and then titrated up to Metoprolol 200 mg PO qday if BP is \>125/80 for the remaining 8 weeks