NCT01395329

Nebivolol and the Endothelin (ET)-1 System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. 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. 2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.

Conditions

• Prehypertension
• Hypertension

Interventions

Type	Name	Description
DRUG	Nebivolol	5 mg tablet to be taken by mouth once per day for 12 weeks
DRUG	Metoprolol	100 mg tablet to be taken by mouth once per day for 12 weeks
DRUG	Placebo	gelatin capsule to be taken by mouth once per day for 12 weeks
OTHER	Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)	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.
OTHER	FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)	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.
OTHER	FBF response to Acetylcholine	The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.
OTHER	FBF response to Sodium Nitroprusside	The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.
OTHER	FBF response to BQ-123+BQ-788+ACh	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2011-07-15
• Last updated: 2019-01-02
• Results posted: 2018-12-06

Locations

1 site across 1 country: United States