Phase 3 N=12 Randomized Double-blind Treatment

A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00648895 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2010

Primary outcome: Primary: Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nebivolol (Drug); Metoprolol ER (TM) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).	—	—

Summary

The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.

Eligibility Criteria

Inclusion Criteria

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion Criteria

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00648895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.