NCT00648895

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 20, 2010

Completed
Last Updated

September 20, 2010

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

March 28, 2008

Results QC Date

July 21, 2010

Last Update Submit

August 30, 2010

Conditions

Hypertension

Keywords

HypertensionBlood pressureNebivololBystolic (TM)Metoprolol ER (TM)

Outcome Measures

Primary Outcomes (1)

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

    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).

    Before treatment and after 10 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Nebivolol

Drug: Nebivolol

2

ACTIVE COMPARATOR

Metoprolol ER (TM)

Drug: Metoprolol ER (TM)

Interventions

NebivololDRUG

nebivolol 10mg, 20mg, 40mg daily dosage, oral administration

Also known as: Bystolic (TM)
1
Metoprolol ER (TM)DRUG

Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Also known as: Toprol XL (TM)
2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forest Investigative Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

NebivololMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesPropanols

Limitations and Caveats

The study was terminated early because of difficulties with enrollment. Only 12 of 30 planned patients were enrolled.

Results Point of Contact

Title
John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
Organization
Forest Laboratories
John.Whalen@frx.com
1-201-427-8259

Study Officials

  • Tatjana Lukic, MD., M.Sc.

    Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2009

Last Updated

September 20, 2010

Results First Posted

September 20, 2010

Record last verified: 2010-08

Locations

US(1)