CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Nebivolol +7 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/NCT01395329
NCT01395329Phase 4Completed

Nebivolol and the Endothelin (ET)-1 System

University of Colorado, Boulder·interventional·Posted Jul 15, 2011·Updated Jan 2, 2019

In Brief

A Phase 4 clinical trial evaluating Nebivolol, Metoprolol, and 6 other interventions for Prehypertension and Hypertension. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2011
Enrollment StartMay 1, 2011
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.0 years ago

Interventions

Nebivololdrug

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprololdrug

100 mg tablet to be taken by mouth once per day for 12 weeks

Placebodrug

gelatin capsule to be taken by mouth once per day for 12 weeks

Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)other

The forearm blood flow response to the endothelin (ET) -1 A receptor blocker BQ-123 (100 nmol/min) for 60 minutes at baseline and at 12 weeks.

FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)other

The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.

FBF response to Acetylcholineother

The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.

FBF response to Sodium Nitroprussideother

The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.

FBF response to BQ-123+BQ-788+AChother

The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.