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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Nebivolol; Drug: Metoprolol ER (TM)

• Registration Number: NCT00648895
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Primary Completion: 2009-07
• Results First Submitted: 2010-07-21
• Status Verified: 2010-08
• Results First Submitted QC: 2010-08-30
• Last Update Submitted: 2010-08-30
• Results First Posted: 2010-09-20
• Last Update Posted: 2010-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nebivolol	Nebivolol
2	Metoprolol ER (TM)	Metoprolol ER (TM)

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).	Before treatment and after 10 weeks	Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Houston, Texas, United States